MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS

Catalog Number UNK HIP ACETABULAR LINER

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problems Unspecified Infection (1930); Joint Dislocation (2374); Not Applicable (3189); No Code Available (3191)

Event Date 12/01/2013

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.[(b)(4)].

Event Description

The literature article entitled, "verification of the australian orthopaedic association national joint replacement registry using a surgeon's database" written by bob jang, nichola a walsh, and warwick jm bruce published by journal of orthopaedic surgery 2013;21(3):347-50 published december 2013 was reviewed.The article's purpose was to report on verification or any discrepancies between a surgeon's database and the australian orthopaedic association national joint replacement registry.Although the article focuses on data entry discrepancies, it is noted that the database was specifically of patients that were revised who had depuy products initially implanted and reasons for revision were provided.Data was compiled from 231 primary tha on 217 patients receiving implants between 2002 and 2005.Depuy products utilized: corail stem, pinnacle cup, asr cup or duraloc, ceramic & poly liners adverse events (reference table on page 349): revisions for: cup loosening, osteolysis (mention of poly wear), infection, ceramic liner fracture, dislocation, poly wear, fractured stem.It is noted that each type of product has been explanted for one or more reasons in the revision procedures.The article does not provide adequate information to determine accurate quantities.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP ACETABULAR LINERS
• Type of Device: HIP ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9315442
• MDR Text Key: 182460078
• Report Number: 1818910-2019-112695
• 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: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention