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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); Scar Tissue (2060)
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Event Date 07/27/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 00575001402 - femoral component - 63241623.00595202110 - articular surface - 63738785.00598002702 - tibial component - 63721655.00579104100 - screw - 63777648.00597206529 - patella - 63572930.Foreign - (b)(6).The customer has indicated that the product will not be returned to zimmer biomet for investigation, as the 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 filed for this event, please see associated reports: 3007963827-2021-00178, 0001822565-2021-02360, 0002648920-2021-00228, 0001822565-2021-02361.
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Event Description
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It was reported that the patient underwent an initial right knee arthroplasty.Subsequently, the patient developed pain, stiffness, and limited range of motion that was unresolved with a manipulation under anesthesia.The patient underwent a revision approximately 3 years post implantation.Attempts have been made and no further information has been provided.
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Event Description
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Upon reassessment of the reported event, it was determined to be not reportable.This is an instrument that was used during surgery, not an implant.The initial report was forwarded in error and should be voided.
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Manufacturer Narrative
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Upon reassessment of the reported event, it was determined to be not reportable.This is an instrument that was used during surgery, not an implant.The initial report was forwarded in error and should be voided.
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Search Alerts/Recalls
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