ZIMMER BIOMET, INC. VERSA-DIAL/COMP TI STD TAPER; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
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Catalog Number 118001 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Failure of Implant (1924); Pain (1994); Synovitis (2094)
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Event Date 11/29/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: item#113032; lot#214780, item# 113610; lot#115800, item#20-8075-004-01; lot#63178536, item#00-4326-040-46; lot#62700439.Remains implanted.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02748, 0001825034-2022-02745.
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Event Description
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It was reported that a patient is to undergo a revision six(6) years post implantation due disassociation and pain.However, no revision procedure has been reported to date.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Associated products and reports: 0001822565-2022-03533 item# 00-4326-040-46; lot# 62700439.0001822565-2022-03555 item# 20-8075-004-01; lot# 63178536.0001825034-2022-02748-1 item# 113032; lot# 214780.0001825034-2022-02745-1 item# 113610; lot#115800.
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Event Description
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It was reported that a patient underwent a revision six(6) years post implantation due disassociation and pain.Attempts have been made and no further information has been provided.
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Event Description
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It was reported a patient had initial left total shoulder arthroplasty approximately seven years ago.Subsequently, the patient, underwent stage one of a two stage revision due to pain and a large, non-contained, glenoid defect.During the surgery, the glenoid was found fragmenting and a synovectomy was performed due to synovitis.All components were removed, and a non-zimmer biomet spacer was placed.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.The following sections were updated/corrected: a2; b4; b5; d10; g3; g6; h1; h2;h3 h6.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Medical records assessed and timeline created.Review of medical records and mmi were assessed.It is noted that the review is for a linked complaint glenoid fracture and are not corresponding to this complaint.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Associated products and reports: 0001825034-2022-02745-2.Item#113610; lot#115800.0001825034-2022-02748-2.Item#113032; lot#214780.0001822565-2022-03533-1.Item00432604046; lot#62700439.0001825034-2023-00191-1.Item#113610; lot#115800.
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