Catalog Number UNK HIP FEMORAL STEM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Metal Related Pathology (4530); Swelling/ Edema (4577)
|
Event Date 07/17/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.Investigation summary = no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required product/lot number was not provided to complete the evaluation.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 device lot number is unknown, therefore a device history review could not be performed. if the lot/serial number becomes available, the record will be re-assessed.E3 initial reporter occupation: lawyer.H6: component code: appropriate term/code not available (g07002) used to capture no findings available.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.
|
|
Event Description
|
On july 17, 2023, plaintiff suffered the following personal and economic injuries as a result of the implantation with the asr hip implant: severe pain and discomfort, increased metal levels in blood including cobalt and chromium; permanent injuries, emotional distress, disability, disfigurement.Doi: (b)(6) 2007, dor: july 17, 2023, right hip.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required product/lot number was not provided to complete the evaluation.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 device lot number is unknown, therefore a device history review could not be performed. if the lot/serial number becomes available, the record will be re-assessed.H10 additional narrative:.
|
|
Event Description
|
Medical records received.The patient had a right hip failed total hip replacement secondary to trunnionosis with pseudotumor.The patient developed pain in (b)(6) 2023.Esr was 30 and crp was <3.0 mg/l.Her metal ions were about 16 and 8 concerning for trunnionosis.Mars mri shows significant fluid collection.Findings were about 30ml of dark fluid was removed and black residue at the base of the trunnion.Necrotic tissue within the back of the femoral head and extending inferiorly.Debrided the necrotic tissue around the acetabulum.
|
|
Search Alerts/Recalls
|
|