MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DURALOC CONST LINER 62/74X28; DURALOC IMPLANT : HIP POLY ACETABULAR LINERS

Catalog Number	124122527
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Codes	Joint Dislocation (2374); Osteolysis (2377); No Code Available (3191)
Date of Event	02/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.(b)(4).
Event or Problem Description
It was reported that the patient was revised due to dislocation, osteolysis and poly wear.A new constrained liner was implanted along with a new head.Doi: unknown; dor: (b)(6) 2019, right hip.
Additional Manufacturer Narrative
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.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.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: DURALOC CONST LINER 62/74X28
• Common Device Name: DURALOC IMPLANT : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8427905
• Report Number: 1818910-2019-87521
• Device Sequence Number: 1341298
• Product Code: KWZ
• UDI-Device Identifier: 10603295018827
• UDI-Public: 10603295018827
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P960054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 124122527
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 04/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR