Model Number N/A |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544); Osteopenia/ Osteoporosis (2651); Swelling/ Edema (4577)
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Event Date 09/07/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10 ¿ oxf anat brg lt sm size 4 pma; item#: 159541, lot#: 811040 oxf twin-peg cmntd fem sm pma; item#: 161468, lot#: 175150 unknown cement 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 underwent revision surgery to a total knee approximately one year and five months post initial left partial knee replacement, due to tibial baseplate loosening.Poor bone quality was noted during the surgery.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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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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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.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Device is used for treatment.Radiographs were provided and reviewed by a radiologist.Three views of the left knee demonstrate a medial compartment hemiarthroplasty with subsidence of the medial tibial component with radiolucency along the cement hardware interface consistent with loosening.Moderate joint effusion and osteopenia was also noted.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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Search Alerts/Recalls
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