SMITH & NEPHEW ORTHOPAEDICS LTD UNKN BIRMINGHAM HIP RESURFACING (BHR) CUP (UNKN TYPE); PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
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Catalog Number UNKN01102102 |
Device Problem
Biocompatibility (2886)
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Patient Problems
Ambulation Difficulties (2544); Metal Related Pathology (4530); Swelling/ Edema (4577)
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Event Date 10/28/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that, after a bhr resurfacing construct had been implanted on the patient¿s left hip on (b)(6) 2009, the patient experienced hip pain, swelling, metallosis, difficulty walking, soft tissue damage and metal-on-metal reaction within the left hip joint.A revision surgery was conducted on 28-oct-2021 to address this adverse event.The identity of the explanted devices and the ones implanted in exchange are not known.Patient¿s current health status is not known.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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H3, h6.It was reported that, after a bhr resurfacing construct had been implanted on the patient¿s left hip on (b)(6) 2009, the patient experienced hip pain, swelling, metallosis, difficulty walking, soft tissue damage and metal-on-metal reaction within the left hip joint.A revision surgery was conducted on 28-oct-2021 to address this adverse event.The identity of the explanted devices and the ones implanted in exchange are not known, and the parts, used in treatment, were not available for analysis.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review, device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions are required.A risk management review was performed for the acetabular cup and femoral head.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.Based on the reported symptoms it cannot be concluded that the events/clinical reactions (soft tissue damage and metal-on-metal reaction) were associated with a mal-performance of the implant.The patient impact cannot be determined at this time.No further clinical assessment is warranted at this time.Without return of the actual devices or further information we cannot further investigate the details supplied in this complaint, our investigation remains inconclusive, and a definitive root cause cannot be determined.Based on the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.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.H11: corrected information is h6 (health effect - clinical code).
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Search Alerts/Recalls
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