Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Pain (1994); Loss of Range of Motion (2032)
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Event Date 03/14/2023 |
Event Type
Injury
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Event Description
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It was reported a patient had an initial right total hip arthroplasty.Subsequently, the patient began to experience moderate pain with a decrease in range of motion approximately 6 years post-implantation.The patient received cortisone injections for right inguinal pain, exacerbated with active hip flexion.The cortisone injections alleviated the pain for three weeks but is now reporting severe pain.No definitive planned intervention has 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 - 00036.0001825034 - 2024 - 00037.D10: cat# 650-1057 lot# 537390 cer bioloxd option hd 36mm.Cat# 650-1065 lot# 329700 cer option type 1 tpr sleve -3.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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No further information at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} component code: mechanical (g04) - stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: right inguinal pain exacerbated with active hip flexion.Reported pain 4/10, denies trauma or falls.Tenderness to groin, abnormal rom with flexion, well healed incision.Right hip flexor tendinitis.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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