Model Number N/A |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Arthritis (1723); Insufficient Information (4580)
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Event Date 10/12/2021 |
Event Type
Injury
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Event Description
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It was reported patient underwent a revision procedure four years post implantation due to unknown reason in knee.Attempts to obtain additional information have been made; however, no more is available at this time.
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Manufacturer Narrative
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(b)(4).D10 ¿ medical product: series a pat thn 34 3 peg catalog # 184786 lot # 361710.Biomet cc cruciate tray 71mm catalog # 141233 lot # j3842692.Vngd ps open intl fem rt 60 catalog # 183104 lot # j3882188.H3: customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001825034-2023-01750, 0001825034-2023-01753, 0001825034-2023-01755, h3 other text : product location unknown.
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Event Description
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Upon receipt of information received and reassessment of the reported event, it was determined to be not reportable.There is no issues with zimmer biomet device, as the event was the result of a patient condition.The initial report was forwarded in error and should be voided.
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Manufacturer Narrative
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Upon receipt of information received and reassessment of the reported event, it was determined to be not reportable.There is no issues with zimmer biomet device, as the event was the result of a patient condition.The initial report was forwarded in error and should be voided.
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Search Alerts/Recalls
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