Model Number N/A |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032); Limited Mobility Of The Implanted Joint (2671)
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Event Date 10/25/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Additional concomitant medical products: liner and shell with plastic barrier 44 mm i.D.54 mm, pn 00151505444, ln 61869990.Multiple mdr reports were filed for this event.Please see reports: 0001822565-2018-06758.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that the patient was 5 years post op.The patient reports dissatisfaction with the hip, uses one crutch for support during ambulation, and has a moderate limp.This was a complaint as the patient reported at the three-year clinical visit improvement in pain and ambulation.Attempts have been made and additional information on the reported event is unavailable at this time.No further information is available.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated biolox⮠option, head, s, 㸠44/-3.0, taper 12/14, (b)(4).Reported event was unable to be confirmed.Device history record (dhr) was reviewed and no discrepancies were found.Root cause could not 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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Event Description
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No further event information available at the time of this report.
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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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Complaint sample was evaluated and the reported event was confirmed.Review of op notes and review of radiographs identified identified the following : the components were anatomically aligned without dislocation or subluxation.The femoral component was varus in position.A small focal radiolucency was present at the most proximal metal-bone interface of femoral component.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmerbiomet will continue to monitor for trends.
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Search Alerts/Recalls
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