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Model Number N/A |
Device Problem
Material Erosion (1214)
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Patient Problems
Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Reaction (2414)
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Event Date 03/31/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: pn 11-163662, ln 466620, 28mm m2a mod head std nk, item# unknown unknown stem lot# unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 08910.
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Event Description
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It was reported that patient underwent initial total right hip arthroplasty on approximately 9 years ago.Patient underwent revision procedure 9 years post initial implantation due to pain, limited range of motion, inflammation, and elevated metal ions.Attempts were made to obtain additional information; however, none was available.
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Search Alerts/Recalls
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