Model Number N/A |
Device Problem
Contamination (1120)
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Patient Problem
Unspecified Infection (1930)
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Event Date 05/02/2014 |
Event Type
Injury
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Event Description
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It was reported patient underwent right total hip arthroplasty (b)(6) 2013.Subsequently, patient underwent procedures on (b)(6) 2014 and (b)(6) 2014 due to infection.The liners were removed and replaced.
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Manufacturer Narrative
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The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.Follow up attempts to obtain additional information pertaining to event details and product identification are in process.Should additional information be received, biomet will forward a supplemental report to the fda.The following sections could not be completed with the limited information provided.Lot number and expiration date - unknow.Manufacture date ¿ unknown.This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2014-04768, 4772).
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
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Event Description
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It was reported that a patient enrolled in a clinical study underwent right total hip arthroplasty on (b)(6) 2013.A revision procedure was performed on (b)(6) 2014 due to infection and the acetabular liner was replaced.Another revision procedure took place on (b)(6) 2014 due to ongoing infection where the acetabular liner and modular head were replaced.A subsequent revision procedure occurred on (b)(6) 2014 to replace the liner and head with a constrained system due to dislocation.A debridement procedure took place on (b)(6) 2014 where the acetabular liner was also revised due to infection.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
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Search Alerts/Recalls
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