(b)(4).Reporting source - (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-03094, 0001825034-2019-03095.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.
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The reported head was returned and evaluated against the complaint.Visual inspection found the head to be enclosed in material similar to the coating of the reinforced stem.The coating is chipped/fractured near the apex of the head.The neck taper is free of damage and debris.Complaint sample was evaluated and the reported event was not confirmed.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.The root cause of the reported issue is attributed to off-label usage; there is no documentation that says that the stageone select hip stem is compatible with items other than the other components in the stageone select hip system, specifically for this case, the neck length adapters: 431186, 431187, & 431188.Specifically for this case because there are stageone select hip heads that go on top of the neck length adapters, but the hip heads are not intended to mate directly with the hip stem, but the stem, head, and neck length adapters are all part of the stageone select hip system.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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