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Catalog Number 010000662 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Ambulation Difficulties (2544)
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Event Date 11/14/2023 |
Event Type
Injury
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Event Description
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It was reported that a patient, with a history of dysplasia, was diagnosed with minimal greater trochanter bursitis approximately four years post implantation.Now, approximately nine years post implantation, the patient is experiencing intermittent pain, severe pain with walking and aggravated pain with lifting leg in a straight position, while lifting the knee, lying and twisting.Pain subsides while sitting and has been diagnosed with psoas tendinitis.The patient is being treated conservatively for the time being and no further notes of an increase in pain have been reported.Attempts have been made and no further information is available.
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00043.0001825034-2024-00044.D10: cat #: 010000856 / g7 neutral e1 liner 36mm d / lot #: 3364238.Cat #: 51-108080 / tprlc 133 mp t1 pps so 8x101mm / lot #: 3391462.Cat #: 6501057 / cer bioloxd option hd 36mm / lot #: 965570.Cat #: 6501065 / cer option type 1 tpr sleve -3 / lot #: 339980.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 will be submitted.
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Event Description
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No additional event information to report at this time.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Dhr was reviewed and no discrepancies related to the reported event were found.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: x-ray review found overall sizing is appropriate.No radiolucency.Normal bone quality.No signs of loosening, impingement, wear, radiolucency.No factors identified to contribute to ongoing pain.Medical records identified pain severe with walking.Right hip pain around ilipsoas area ongoing since surgery.Chronic back pain and psoas tendinitis.Complaint is confirmed based on the provided medical records.A definitive root cause cannot be determined.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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Search Alerts/Recalls
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