ZIMMER MANUFACTURING B.V. LINER STANDARD 32 MM I.D. FOR USE WITH 50/52/54 MM O.D. SHELLS; PROSTHESIS, HIP
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Model Number N/A |
Device Problems
Unstable (1667); Device Dislodged or Dislocated (2923)
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Patient Problems
Fall (1848); Hematoma (1884); Pain (1994); Joint Dislocation (2374); Osteopenia/ Osteoporosis (2651); Swelling/ Edema (4577)
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Event Date 09/23/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 00-8777-032-04 biolox delta option fem head, 32mm, +7mm lot#3016713.00-6202-054-22 tm modular cup 54mm cluster-hole lot#60116440.00-6250-065-40 bone screw 6.5x40 selftap lot#60097476.00-6250-065-40 bone screw 6.5x40 selftap lot#60124936.The device will not be returned for analysis, as the device was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 03098.
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Event Description
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It was reported the patient underwent initial left total hip arthroplasty.Subsequently the patient was revised a second time due to dislocation and dissociated femoral head from falling off step approximately 17 years after the initial tha.During the revision a hematoma, swelling, scar tissue, inaccessible femoral head, and bone loss were noted.The head, cup, liner, and screws were exchanged without complications.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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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.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient was revised for dislocation and the head dissociating from the trunnion.A hematoma was noted upon entry into the joint.The shell and liner had to be removed to access the femoral head.Zimmer products were implanted and range of motion was good.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.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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Event Description
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No further event information available at the time of this report.
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