Catalog Number UNK HIP FEMORAL SLEEVE SROM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Fever (1858); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)
|
Event Date 10/06/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Product complaint #: (b)(4).The device catalog number is unknown; therefore, udi is unavailable.Initial reporter occupation: lawyer.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Pinnacle mom litigation records received.Litigation alleges revision due to heavy metal poisoning from toxic metals resulting to pain, pseudotumor, trunnionosis, tissue destruction, metal wear, loss of enjoyment of life, limited adl, emotional trauma and distress.On (b)(6) 2021: incision and drainage of shoulder deep abscess and hematoma with left shoulder myolitis with incomplete collection.On (b)(6) 2021.Patient was revised due to right total hip arthroplasty painful metallosis with superimposed concern for periprosthetic infection.Also reported of cobalt poisoning.Doi: (b)(6) 2006; dor: (b)(6) 2021; hip unknown.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Review of the x-ray evidence found nothing indicative of a device nonconformance or a relation between the product and the reported event.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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
|
Affected side: right hip.
|
|
Search Alerts/Recalls
|