Catalog Number 166575 |
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); Swelling/ Edema (4577)
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Event Date 12/15/2014 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10: medical devices: oxf twin peg cmntls fmrl md; item# 161474; lot# 2407046; oxf anat brg rt md size 3 pma; item# 159575; lot# 533620.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2023-00286, 3002806535-2023-00287.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Event Description
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It was reported that the patient experience knee pain and stiffness approximately four months after unicondylar knee arthroplasty.This was treated with a cortisone injection in the knee.The pain and stiffness persisted until three months later when a parapatellar effusion was aspirated.Following the aspiration, the patient continued to show improvement in pain and function.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Devices are used for treatment.Medical records and radiographs were provided and reviewed by a health care professional.Moderate occasional pain, pain and difficulty increased, limping while walking at all times, continues using cane for support.Additional medical intervention provided due to pain and swelling.With the available information, a definitive root cause cannot be determined.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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