SMITH & NEPHEW ORTHOPAEDICS LTD BIRMINGHAM HIP RESURFACING (BHR); PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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Catalog Number 74120144 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Toxicity (2333); Limited Mobility Of The Implanted Joint (2671)
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Event Date 05/13/2016 |
Event Type
Injury
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Event Description
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It was reported that a scheduled bhr right hip revision surgery will be performed due to pain, limited mobility, pseudotumor and elevated metal ion levels.
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Manufacturer Narrative
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It was reported that a scheduled bhr right hip revision surgery will be performed due to pain, limited mobility, pseudotumor and elevated metal ion levels, to date no revision has been reported.As of today, additional information has been requested for this complaint but has not become available.Without the details of the devices involved in this complaint, the manufacturing review, complaint history review, specific product labelling and ifus & risk management for the devices cannot be reviewed.If this information becomes available at a later time, the task will be reopened and completed.With the limited information provided the root cause of the reported pain, limited mobility, pseudotumour and elevated metal ions cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.
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Event Description
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It was reported that a bhr right hip revision surgery was performed on (b)(6) 2023.Due to pain, limited mobility, pseudotumor and elevated metal ion levels.The current state of health of the patient is unknown.The primary right hip surgery was performed on (b)(6) 2008.
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Event Description
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It was reported that a bhr right hip revision surgery was performed on (b)(6) 2023.Due to pain, limited mobility, pseudotumor and elevated metal ion levels.The revision was completed with an actis size 8 standard offset stem, 28+1.5 biolox delta endoposthetic head, and a smith and nephew polar head, 28.X 50 inside to outside diameters.The primary right hip surgery was performed on (b)(6) 2008, and on 13/may/2016 the patient underwent a right hip aspiration that indicated pink, cloudy synovial fluid as well as elevated metal ion levels.The current state of health of the patient is unknown.
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Search Alerts/Recalls
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