Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abrasion (1689); Skin Infection (4544)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product remains implanted.The investigation is in process and a follow-up mdr will be submitted upon completion.Https://doi.Org/10.1007/s00264-021-05152-9.
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Event Description
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It was reported in a journal article that 2 patients in the standard-length stem group skin abrasions during broaching with subsequent superficial infections.Both were treated conservatively with oral antibiotics and wound care.The abrasions were seen around the skin just proximal to the incision.All components remain implanted.Attempts have been made and additional information on the reported event is unavailable at this time.
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Event Description
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No additional event information to report at this time.
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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/corrected updated: g3; h2; h6 reported event was unable to be confirmed due to limited information provided by the customer.Dhr was unable to be reviewed as the lot number for the device is unknown.The root cause is 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.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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