ZIMMER BIOMET, INC. PARTIAL ARTICULAR SURFACE RIGHT MEDIAL SIZE E 8 MM THICKNESS; PROSTHESIS, KNEE
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Model Number N/A |
Device Problem
Unstable (1667)
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Patient Problem
Pain (1994)
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Event Date 04/30/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Age or dob: (b)(6).Concomitant medical products: 42558000402, partial femur cemented, lot # 63532896.42538000502, partial tibia cemented, lot # 63881381.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 04430, 3007963827 - 2019 - 00295.
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Event Description
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It was reported that approximately 1 year post implantation, the patient was treated for pain and instability.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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Event occurred in the (b)(6).If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information available at the time of this report.
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Event Description
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It was reported that approximately 1 year post implantation, the patient was treated for pain and instability.Initial operative notes did not identify any intraoperative complications.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, b6, g4, g7, h2, h6, h10.The product was evaluated through manufacturing review and the complaint was confirmed through review of medical records.The device history records could were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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