MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DURALOC CONST LINER 54X32; DURALOC IMPLANT : HIP POLY ACETABULAR LINERS

Catalog Number	124214527
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the surgeon put in a constrained liner and did not fully engage into head.Went to put in constrained liner ring and the head popped out because its not fully engaged.Extracted liner and tried to remove liner ring.It would not come out so they switched to a regular duraloc liner 10 degree.Doe: (b)(6) 2018.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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.Device history lot : (b)(4).Device history review: no anomalies or deviations were found.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DURALOC CONST LINER 54X32
• 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: 7685091
• Report Number: 1818910-2018-64388
• Device Sequence Number: 13624191
• Product Code: KWZ
• UDI-Device Identifier: 10603295019176
• UDI-Public: 10603295019176
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P960054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 124214527
• Device Lot Number: HU2187
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 08/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1