Catalog Number 650-1065 |
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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Manufacturer Narrative
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(b)(4).D10 - associated medical devices: cer bioloxd option hd 36mm; item# 650-1057; lot# 537390.Tprlc 133 type1 pps so 9x137mm; item# 51-103090, lot# 3880920.G7 finned 3 hole shell 52e; item# 110017103; lot# 3841407.G7 neutral e1 liner 36mm e; item# 010000857; lot# 3915013.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2024-00015.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 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.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.The products remain implanted; therefore, visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Devices are used for treatment.Medical records were provided and reviewed by a health care professional.The review identified normal rom, leg lengths were equal, anterior right hip pain ad inflammation with flexion and internal /external rotation.Surgeon discussed option of downsizing cup.With the available information, a definitive root cause could not 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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