MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

An article ¿cumulative revision rate is higher in metal on metal tha than in metal on polyethylene tha: analysis of survival in a community registry¿ by der-chen t.Huang reports on whether higher-cost mom tha implants were superior to moxp tha implants in terms of implant survival and whether survival differed between the depuy asr mom implant and other mom tha implants.It also analyses if revision for dislocation was more common in moxp or mom thas.Total 2404 patients (mom thas-1118 and moxp thas-1286); who underwent hip and knee arthroplasties from 1999 to 2001 were included in the study.Of the 1118 mom thas (mean age = 62 years, 535 male and 583 females), 423 used asr (depuy) implants, 692 used pinnacle (depuy) implants, and there were three other mom devices.73 out of 1118 cases underwent to revision surgery due to dislocation, periprosthetic fracture, failure of bone ingrowth, aseptic loosening, infection, pain, metal hypersensitivity, pseudotumors, metallosis and other (unknown) reasons.Location of fracture is not specified.Incidence of pseudotumor related to metallic debris was also documented by the operative surgeons.Asr implant was found to be associated with above reported adverse events.

Manufacturer Narrative

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.H10 additional narrative: product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds IN LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 8876586
• MDR Text Key: 153825796
• Report Number: 1818910-2019-100605
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention