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.

• 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
• 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: 8708518
• MDR Text Key: 148326787
• Report Number: 1818910-2019-96196
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• 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

• Device Catalogue Number: UNK HIP POLY ACETABULAR CUPS
• 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: 08/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/18/2019 Patient Sequence Number: 1