Catalog Number 00811400100 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bone Fracture(s) (1870); Joint Dislocation (2374); Muscle/Tendon Damage (4532); Unequal Limb Length (4534)
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Event Date 06/30/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-01974, 0001822565-2023-01975.G2: australia.D10: cat #: 802203202 / femoral head 12/14 taper 32 mm diameter +0 mm neck length / lot #: 3120473; cat#: 00800565432 / acetabular cup for cemented use only id 32 mm 10 degree inclined face od cup with spacers 57 mm / lot #: 64801070.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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It was reported a patient underwent a hip revision approximately two months¿ post implantation due to a dislocation.A small avulsion of the posterior greater trochanter noted at start, as well as ruptured fascial repair.Attempts were made at closed reduction but were unsuccessful.It was then decided to complete an open reduction.The head was exchanged without any known complications.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Component code: mechanical (g04) - stem.The reported event was confirmed by review of medical records.A healthcare professional reviewed the records and identified that the patient was reportedly sitting in bed when they went to turn, felt a pop in the hip, and had dislocated posteriorly with rotation found.Patient underwent an open reduction and head exchange.A small avulsion of the posterior greater trochanter was noted at the beginning of the procedure, as well as a ruptured fascial repair.No complications were noted post-op.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No additional information.
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Search Alerts/Recalls
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