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

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Test Result (2695); Not Applicable (3189); No Code Available (3191)

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 ¿one component revision of failed hip resurfacing from adverse reaction to metal wear debris¿ by james w pritchett et al reports on the results of 90 one- component revisions in 89 patients (46 males, 43 females; mean age 49.8years) for failed hip resurfacing due to adverse reaction to metal wear debris (76 acetabular, 14 femoral).The following primary resurfacing components were used - birmingham hip resurfacing system, conserve plus total resurfacing hip system, cormet hip resurfacing system, asr hip resurfacing system, recap total hip resurfacing system, durom hip resurfacing system.The asr hip resurfacing system was employed in 8 cases.All cases of revision surgery were presented with pain, noise, instability, effusion and elevated blood cobalt levels.Failure was happened due to acetabular fracture, continuing metallosis, infection and loose acetabulum let to revision surgery.Histological examination of peri prosthetic tissues of all patients confirmed an adverse reaction to metal debris.Extensive fibrinous necrosis was found in most cases.No clarification was found on which events were specifically present on specific patients.Asr hip resurfacing system 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.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.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.Device history lot: null.Device history batch: null.Device history review: null.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 HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 8830504
• MDR Text Key: 152320404
• Report Number: 1818910-2019-99290
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 07/26/2019
• Supplement Dates Manufacturer Received: 08/23/2019
• Supplement Dates FDA Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention