Model Number N/A |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Pain (1994); Joint Dislocation (2374); Swelling/ Edema (4577)
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Event Date 06/13/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Medical devices: oxf twin peg cmntls fmrlmd; item# 161474; lot# r2503466a; oxford cementless tibia dlm;item# us166576; lot# r3050476a.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.
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Event Description
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It was reported, that the patient suffered a bearing dislocation.A lidocaine injection was administered.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.The following sections were updated: b4, b5, g3, g6, h1, h2, h6, h10 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Devices are used for treatment.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found 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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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.D10 - medical devices: oxf twin peg cmntls fmrl md; item# 161474; lot# r2503466a.Oxford cementless tibia d lm; item# us166576; lot# r3050476a.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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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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Cmp-(b)(4) this follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b3, b4, b5, g3, g6, h2, h3, h6, h10.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint history identified additional similar complaints for the reported item and the part and lot combination.Complaints are monitored in order to identify potential adverse trends.With the available information, a definitive root cause could not be determined.If any further information is found that 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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