Catalog Number UNK HIP FEMORAL HEAD METAL |
Device Problem
Naturally Worn (2988)
|
Patient Problems
Adhesion(s) (1695); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)
|
Event Date 01/01/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary : no device associated with this report was received for examination.The adverse symptoms alleged and product code reported is associated with the depuy metal on metal articulation.A complaint database search and/or device manufacturing (dhr) reviews will not be 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: a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.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
|
Litigation records alleges heavy metal poisoning from the toxic heavy metals released by the pinnacle system resulting in injury and requiring surgery to remove the defective hip replacements.Patient was consequently revised due to injury to muscle and tissue, suffered additional scar tissue formation, and now has a hip replacement with decreased longevity.Additionally, patient suffered pain, injury caused by metallosis, metal wear, metal poisoning, loss of enjoyment of life, limitation of daily activities, incurred additional medical expenses, lost earning potential/ income, and ultimately emotional trauma and distress in the future.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).Doi: (b)(6) 2007.Dor: (b)(6) 2021.Unk hip.
|
|
Search Alerts/Recalls
|
|