BIOMET UK LTD. OXFORD UNICOMPARTMENTAL KNEE PHASE 3 ANATOMIC ARCOM MENISCAL BEARING; PROSTHESIS, KNEE
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Model Number N/A |
Device Problems
Material Erosion (1214); Migration or Expulsion of Device (1395); Unstable (1667); Metal Shedding Debris (1804)
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Patient Problems
Pain (1994); Reaction (2414)
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Event Date 06/13/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products ¿ oxford femur catalog 154601 lot 1447847; oxford tibial tray size d catalog 154725 lot 1278419.Customer has not indicated whether product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2017-00541, 3002806535-2017-00543, 3002806535-2017-00542.
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Event Description
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It was reported a patient underwent a revision procedure to convert from a right partial knee prosthesis to a total knee approximately seven years post implantation due to pain, wear, instability, and arthroplasty collapse with migration.The patient reportedly began experiencing pain and instability approximately three and a half years post-operatively, however no issues were found until the patient began experiencing worsening pain approximately seven years post-operatively.The femoral and tibial components were said to have been in contact with one another and were noted to have evidence of gross abrasive wear.The tibial bearing was also noted to evidence asymmetrical wear.
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Manufacturer Narrative
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This follow-up report is being filed to relay this report is a duplicate of 3002806535-2017-00285.
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Search Alerts/Recalls
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