UK – MHRA medical device alerts

MHRA medical device alerts

The Medicines and Healthcare products Regulatory Agency(MHRA) release medical device alerts when a healthcare product is not performing to the appropriate standards.The following relevant alerts have been released by the MHRA:

• MDA/2010/069; Medical Device Alert: ASR hip replacement implants manufactured by DePuy International Ltd
• MDA/2010/033; Medical Device Alert: All metal-on-metal (MoM) hip replacements
• MDA/2009/062; Medical Device Alert: Knee Replacement Implant. DePuy PFC Sigma cruciate retaining non-porous size 5 left femoral component (part no 96005) specific lot numbers
• MDA/2009/046 ; Medical Device Alert: Modular knee/hip replacement systems – MRS Cemented Stems manufactured by Stryker Orthopaedics
• MDA/2009/037 ; Medical Device Alert: Knee replacement implant manufactured by DePuy International Limited
• MDA/2009/016 ; Total knee replacement implant femoral components – PFC SIGMA. Manufactured by DePuy International Limited
• MDA/2008/066 ; Total knee replacement implants: Stryker Orthopaedics Kinemax Plus Revision TS Tibial Inserts
• MDA/2008/003 ; Total knee replacement implants. VKS, RT-Plus and TC-Plus femoral and tibial knee components manufactured by Plus Orthopaedics/Smith & Nephew Orthopaedics Ltd (specific lot numbers)
• MDA/2008/003; Total knee replacement implants. VKS, RT-Plus and TC-Plus femoral and tibial knee components manufactured by Plus Orthopaedics/Smith & Nephew Orthopaedics Ltd; specific lot numbers (January 2008)
• MDA/2007/092; Total knee replacement implants. VKS, RT-Plus and TC-Plus femoral and tibial knee components manufactured by Plus Orthopaedics/Smith & Nephew Orthopaedics Ltd; specific lot numbers (December 2007)
• MDA/2007/ 067; Hip resurfacing implants. Adept acetabular cups manufactured by Finsbury Orthopaedics (August 2007)
• MDA/2007/ 063; Hip resurfacing implants. Birmingham Hip Resurfacing (BHR) acetabular cups manufactured by Smith ; Nephew Orthopaedics Ltd (August 2007)
• MDA/2007/ 054; Total hip replacement: DePuy Ultima TPS femoral stem used in combination with Ultima metal-on-metal articulation (June 2007)
• MDA/2004/ 011; ABG I Uncemented Acetabular Cups for Total Hip Replacement (March 2004)

The NJR is unable to offer any advice in relation to MHRA medical device alerts. For more information about specific alerts please visit the MHRA website.

 

Technorati Tags: Aseptic Loosening, Cobalt Ions, Cobalt Poisoning, DePuy, DePuy Lawsuit, Hip failure, Hip recall, Hip Replacement, Stryker, Finsbury Orthopaedics, Knee Replacement, Birmingham Hip Replacement

 

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