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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
Nerve Damage (1979); Pain (1994); Loss of Range of Motion (2032); Numbness (2415); Tissue Breakdown (2681); Swelling/ Edema (4577)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical devices: ref 113849 lot 415130 biomodular keeled glenoid; ref 113647 lot 864650 comprehensive stem.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 01890; 0001825034 - 2021 - 01891.
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Event Description
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It was reported that the patient underwent a left shoulder replacement.Almost ten years later, the patient has reported constant pain, limited daily activities, loss of feeling in her hand, and mobility loss.She has received steroid injections for inflammation and spasms.No revision has been scheduled to date.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.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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It was reported that the patient underwent a left shoulder replacement.Almost ten years later, the patient has reported constant pain, limited daily activities, loss of feeling in her hand, and mobility loss.She has received steroid injections for inflammation and spasms.No revision has been scheduled to date.Additionally it was reported that the muscle is detaching from the arm and device is coming up through the skin.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, g3, h2, h3, h6 reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies related to the event were found.Root cause was unable to be determined.Medical records identified the following: no intra-op complications identified during the initial surgery.Patient stated she was having pain, limited daily activities, balance issues, range of motion issues, inability hold on to things, sleep loss, loss of feeling in her hand, neck and back issues.Patient stated she went to the er due to inflammation and spasms after receiving steroid injections.During that visit, she was told the metal was coming through her skin.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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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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