(b)(4) customer has indicated that the product will not be returned to zimmer biomet for investigation, due to unknown product location.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Unique identifier (udi) #: n/a.Concomitant medical products: 010000858, g7 neutral e1 liner 36mm f, 6237888; 193011, echo b-mtrc mp fp so 11, 551060; 650-1057, cer bioloxd option hd 36mm, 2907284.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 04750; 0001825034 - 2018 - 04751; 0001825034 - 2018 - 04752.
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It was reported patient underwent an initial left hip procedure.Patient then reported an acute onset of progressive pain and swelling for 6 days following a gastrointestinal illness approximately a month and a half post surgery.Subsequently, patient underwent a hip revision surgery due to pain, swelling, and infection less than 2 months post implantation.
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This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of clinical notes.Pre-revision office visit notes confirm that the patient underwent explant of the of the total hip with placement of an antibiotic-coated articulating spacer due to infection.The returned shell component remained assembled with the returned liner.Scratching was observed on the rim of the shell.Foreign material also remained affixed to the shell¿s porous coating.The liner was held firm with no movement allowed in any direction.The inner radius of the liner was scratched and pitted.Gouging was observed on the liner¿s rim.Visual inspection found scratches and gouges on the neck of the stem.Foreign material remained affixed to the porous coating of the stem.No damage was observed on the distal tip of the stem.Visual inspection found scratching on the outer radius and rim of the head.The taper insert of the head was also gouged.A surgical mallet, punch and generic stem were used to remove the taper from the head.No damage was observed on the inside of the taper or the inside of the head.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.Zimmer biomet will continue to monitor for trends.
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