MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 DURALOC CONST LINER 56/68X32; HIP POLY ACETABULAR LINERS

Catalog Number	124216527
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/04/2017
Type of Reportable Event	Serious Injury
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
Patient was revised for acute dislocation.The same implants were reimplanted.
Additional Manufacturer Narrative
(b)(4).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.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 56/68X32
• Common Device Name: HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 7154022
• Report Number: 1818910-2017-52706
• Device Sequence Number: 13899810
• Product Code: KWZ
• UDI-Device Identifier: 10603295019206
• UDI-Public: 10603295019206
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P960054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2017

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 124216527
• Device Lot Number: 203426
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 01/26/2018
• 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: 76 YR
• Patient Weight: 88