BIOMET ORTHOPEDICS UNIVERSAL ALTERNATIVE BEARING SHELL 62MM 2-HOLE WITH SCREW 41 MM I.D.; PROSTHESIS, HIP
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Model Number N/A |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant products: 15-105004 021690 m2a taper liner 32mm i.D.Size 41mm o.D.Taper; 11-163669 859270 m2a odular head compnent 32mm head diameter standard neck; 103207 675870 modual taperloc femoral porous coated 13.5 x 147mm type i taper.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-03600; 0001825034-2017-03601; 0001825034-2017-03602.
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Event Description
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It was reported that the patient experienced pain, dislocation, metallosis, component loosening, elevated metal ion levels and lack of mobility post-implantation.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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