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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032); Limited Mobility Of The Implanted Joint (2671)
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Event Date 09/02/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source: (b)(6).Concomitant medical products: catalog number:010000700 lot number: 3395124 brand name:g7 bonemaster ltd, catalog number:010000846 lot number: 3464197 brand name:g7 neutral e1 liner, catalog number:51-199334 lot number:unknown brand name:sirius hip stem 34-c, catalog number:51-199300 lot number: unknown brand name: sirius winged centralizer, catalog number:650-1163 lot number: 3377385 brand name:delta cer fem hd 32/-3mm t1.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-04915, 0001825034-2019-04916, 0001825034-2019-04917, 0001825034-2019-04918.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted in the patient.
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Event Description
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It was reported that the patient reported moderate pain, a new onset slight limp, some limitations with adls, and decrease in overall satisfaction and health state scores approximately 3 years post implantation.No revision has been reported to date.Additional information on the reported event is unavailable.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.D11: catalog number:51-199334 lot number: 202470 brand name: sirius hip stem 34-c.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: (summarized by hcp).Findings: 1 year follow up: o hhs 87.9, slight pain, functional activities with ease, normal gait, lld 0cm o eq5d 0.827, moderate pain, no problems performing activities, health state 100.3 year follow up: o hhs 65, moderate pain with some limitation of activity, slight limp, lld 1cm, o eq5d 0.378, moderate pain, some problems with activities, health state 30.Reported event was confirmed by review of medical records provided.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.
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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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