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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); Scar Tissue (2060)
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Event Date 09/04/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10: (b)(6), item name g7 10 deg e1 liner 36mm g, lot # 3959772.(b)(6), item name g7 bonemaster ltd acet shl 60g, lot # 6332149.G2: foreign: australia.Multiple mdr reports were filed for this event, please see associated reports: 0001825034- 2023-02162.0001825034-2023-02160.The device will not be returned for analysis as it remains implanted; 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 that the patient underwent a revision procedure 7 months post implantation due to pain, possible poly disimpaction and instability.During the surgery, the poly was found intact and extensive scar tissue was debrided.Only the head was revised, and the procedure was completed without complication.There is no additional information available at the time of this report.
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Event Description
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There is no update to the prior event description provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.D4: expiration date and udi.H6: component code: mechanical (g04) - stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Complaint confirmed based on evaluation of the provided medical records.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: x-ray review: there is no abnormal radiolucency or evidence of implant loosening.There is malalignment with subluxation/dislocation as noted.Records review: unstable, extensive scar tissue- debrided.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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Search Alerts/Recalls
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