MAUDE Adverse Event Report: DEPUY INT'L LTD. 8010379 UNKNOWN HIP ACETABULAR LINERS

Catalog Number UNK HIP ACETABULAR LINER

Device Problems Nonstandard Device (1420); Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Joint Dislocation (2374); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(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.

• Brand Name: UNKNOWN HIP ACETABULAR LINERS
• Type of Device: HIP ACETABULAR LINERS
• Manufacturer (Section D): DEPUY INT'L LTD. 8010379; st anthony's rd; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380-0988 ; 6103142063
• MDR Report Key: 8876598
• MDR Text Key: 153794187
• Report Number: 1818910-2019-100607
• Device Sequence Number: 0
• Product Code: KWY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/01/2019
• 2 Devices were Involved in the Event: 1 2

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

• Device Catalogue Number: UNK HIP ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011

Patient Treatment Data

Date Received: 08/08/2019 Patient Sequence Number: 1