ZIMMER BIOMET, INC. RETENTIVE POLY LINER PLUS (+) 6 MM OFFSET 36 MM DIAMETER 65 DEGREE NECK ANGLE; PROSTHESIS, EXTREMITIES
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Catalog Number 00434906506 |
Device Problems
Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
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Patient Problems
Pain (1994); Joint Dislocation (2374)
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Event Date 02/10/2020 |
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 associated reports: 0001822565-2020-02237, 0001822565-2020-02245.Concomitant medical products: stem - part # 00435001313, lot# 63754535.Unk glenoid head.Product has been received by zimmer biomet and the investigation is in process.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.
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Event Description
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It was reported patient underwent a reverse shoulder arthroplasty approximately five (5) months ago.Approximately one (1) month post implantation, patient underwent a revision due to pain, dislocation, and the poly liner disengaging from the stem.Surgeon only removed and replaced a new poly liner.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.A poly liner was returned for evaluation.Visual inspection of the liner identified it to have damages; nicks, gouges, scratches and deformation.The damages were likely caused during an attempt to remove the liner.A dimensional analysis cannot be identified due to the nature of the damages.Medical records / radiographs were provided and reviewed identified open reduction and revision of right rtsa humeral component, poly spacer.Presented with increased pain, x-ray showed a dislocated shoulder.Closed reduction attempted but unsuccessful.Upon opening, the humeral poly component was noted to be displaced anterior and off the humeral stem.X-rays were not sent for mmi review as they do not enhance the investigation.Device history record reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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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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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