MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP POLY ACETABULAR CUPS

Catalog Number UNK HIP POLY ACETABULAR CUPS

Device Problems Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pulmonary Embolism (1498); Unspecified Infection (1930); Injury (2348); Joint Dislocation (2374); Impaired Healing (2378); 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 literature article was received entitled "the angle-bore acetabular component and dislocation after revision of a failed total hip replacement¿.The article was reviewed on 29-may-2019 for mdr reportability.The purpose of the study was to determine if the angle-bore socket helps reduce dislocations after previous revisions.The study included 1039 patients that had been previously revised and had a depuy angle-bore socket placed.The cement, stem, and femoral head used are all unknown at this time.The complications/revisions experienced and number of patients involved are noted below that involve the angle-bore socket.Post op complications: delayed wound healing (37), deep infection (17), pe (non-fatal) (36), cardiovascular (16), dislocation-both early and late (95).Revisions: infection (27), dislocation (22), loose angle bore socket (8), loose femoral acetabular component (46) was also noted, but its unknown at this time what the author was indicating to be loose.

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 code(s) 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.Corrective action was not indicated.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 POLY ACETABULAR CUPS
• Type of Device: HIP POLY ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8708518
• MDR Text Key: 148326787
• Report Number: 1818910-2019-96196
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP POLY ACETABULAR CUPS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention