Catalog Number 00434901213 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Osteopenia/ Osteoporosis (2651); Subluxation (4525)
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Event Date 10/18/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event; please see the associated reports: 0001822565 - 2023 - 02991.D10: concomitant medical products - part number (lot number): 00434901213 (63700625).Associated product information: 00434901500 (63715593).00434904011 (63653808).01.04223.036 (2921546).01.04223.036 (2921529).G2: foreign - event occurred in denmark.The customer has indicated that the product is in the 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 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 that the patient underwent a previously reported reverse arthroplasty revision surgery one (1) year and ten (10) months ago due to the poly component disassociating from the stem.Subsequently, the patient underwent a second revision approximately one (1) week ago due to the poly component disassociating from the stem and partial subluxation.The poly was removed and replaced with a spacer and a retentive liner.No other patient consequences were reported as a result of the event.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.H6: proposed component code - mechanical (g04)- stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: a reverse-type left shoulder arthroplasty has been performed.There is no fracture or implant loosening.There is malalignment of the glenosphere-humeral articulation consistent with polyethylene fracture, wear or displacement.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.
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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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