Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032)
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Event Date 01/21/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical devices: 11-301021 arcos stem 753680; 650-1055 bioloxd option hd 428120; 650-1066 tpr sleve 779450; 87-3435 depuy liner 7930873; unknown, unknown cup unknown; 298.801.01s depuy cable 1.7mm p314617; 298.801.01s depuy cable 1.7mm p314617; 298.801.01s depuy cable 1.7mm p314617; 298.801.01s depuy cable 1.7mm p310298; 298.801.01s depuy cable 1.7mm p313427; 1622022-1001 lifenet cortical strut unknown; 1619380-1000 lifenet cortical strut unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product remains implanted.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: 0001825034 - 2021 - 00463.
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Event Description
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It was reported that the patient underwent a left tha on an unknown date.The patient was revised several times.The patients' legal attorney claims that the patient continues to suffer from pain, lost mobility and a leg length discrepancy as a result of the last revision surgery.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.A definitive root cause cannot be determined, however a competitor liner was implanted during the revision in 2013 and this would be a incompatible device, it is unknown if this compatibility issue would of caused or contributed to the events.If any further information is found which would change or alter any conclusions or information, a supplemental report 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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Search Alerts/Recalls
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