Catalog Number 121720500 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Osteolysis (2377); Unspecified Musculoskeletal problem (4535)
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Event Date 01/03/2024 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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Subject id: (b)(6); study no: dots.Clinical notification received for revision due to periprosthetic fracture.Date of implant: (b)(6) 2023, date of revision: (b)(6) 2024, (left hip).Treatment: stem and head were revised.Medical records review (b)(6): on (b)(6) 2024, patients left total hip was revised to address chronic infection with progression of periprosthetic osteolysis of both femoral and acetabular bone.During the revision surgical procedure, it was identified that the femoral stem was loose, that it had only a fibrous ingrowth.There was an osteolytic defect beneath the superior aspect of the acetabular cup, but the cup was well-fixed.There was osteolysis of the femoral canal.The stem, femoral head, cup, liner and two acetabular screws were all explanted.A temporary antibiotic spacer, made up of an antibiotic cemented depuy summit stem, was cemented in place along with stimulant pellets, and paired with a bipolar head.Two synthes cerclage cables were placed on the proximal femur to address a calcar fracture that occurred intraoperatively during broaching for the spacer summit stem.The patient tolerated the procedure well, with no other complications apart from the calcar bone fracture caused by the summit broach.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary - no device associated with this report was received for examination.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot - the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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