Catalog Number 121706070 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Osteolysis (2377); Swelling/ Edema (4577)
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Event Date 04/28/2022 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).E3 initial reporter occupation: lawyer 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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The patient was revised due to pain, pseudotumor, and metallosis of the left hip secondary to failed metal-on-metal bearing surfaces.It was also noted there was atleast 50% loss of bone around the entire acetabular component.The cup was well fixed and further attempts to remove the cup with palpitation revealed to be quite solid to the remaining bone.The cup was not removed.The patient's greater trochanter and entire proximal femur had disappeared secondary to osteolysis.Ct scan reported of large periprosthetic fluid collection.Doi: (b)(6) 2007 dor: (b)(6) 2022 (metal liner and head) left hip.
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Event Description
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Medical records received.Doi: (b)(6) 2007: male patient with a history of left hip femoral fracture, left hip competitor orif, left hip competitor tha, acetabular and femoral osteolysis, and chronic sepsis infection received a depuy mom revision tha as stage 2 treatment of infection.The acetabular cup was secured with a dome screw and the acetabular osteolysis required bone grafting.The previous femoral fracture site was partially healed and required a larger bone cut and the use of an s-rom stem and sleeve.The surgeons noted there was some shortening of the left leg because of the preexisting fracture caused by an mva.The procedure was completed without complications.Ct scan and preoperative testing (b)(6) 2024: a male patient is referred for revision surgery after failed attempts at treating chronic left hip pain.Preoperative aspiration does not detect elevated serum or synovial heavy metal ions but does detect elevated inflammatory markers.Ct scans identify a large pseudotumor as well as extensive acetabular and femoral osteolysis.These were preexisting events and are part of the treatment of revision captured on (b)(4).
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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 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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