ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING 44MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION
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Catalog Number 115370 |
Device Problems
Positioning Failure (1158); Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/02/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4) d10: associated product information, part number (lot number): ¿ unknown bearing (unknown) g2: foreign - the event occurred in the united kingdom the customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found that 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 during a total shoulder arthroplasty, the surgeon was attempting to seat the polyethylene bearing within the humeral tray using manual pressure on the back table.After multiple attempts, the implants assembled.The surgeon noted that the ring appeared to be bent initially, and after assembly, the metal ring was observed to be fractured at the edge of the ring, resulting in the tray and polyethylene bearing coming apart with little effort.The surgeon used a backup tray and the original bearing to complete the procedure without further issues.There was no harm to the patient as a result of the malfunction.Attempts have been made, and no further information has been provided.
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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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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g2; g3; g6; h1; h2; h3; h6.Visual examination of the provided pictures identified the ring broke on the device.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.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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