Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Pain (1994); Swelling/ Edema (4577)
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Event Date 09/14/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent a left total knee arthroplasty with pcl release.Subsequently, the patient developed pain and swelling.An irrigation and debridement procedure with articular surface exchange was completed approximately 2 months later after knee aspirate tested positive for staph aureus.The patient was noted to be improving on iv antibiotics at their two week follow-up visit and approximately 6 weeks later the infection was documented as resolved.Attempts have been made and all available information has been provided.
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 42532007101 - natural tibia cemented 5 degree stemmed left size e - 65294537; 42512200511 - articular surface fixed bearing ultracongruent (uc) left 11 mm height - 64989439; 42540000035 - all poly patella cemented 35 mm diameter - 65355984; unknown - unknown cement - unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2022-00293; 3007963827-2022-00294; 0002648920-2022-00232.
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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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This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2 upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.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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Search Alerts/Recalls
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