MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC 1818910 J-LOC 46MM X 28MM ID 10 DEGREE; MISCELLANEOUS HIP CUP/LINER : HIP POLY ACETABULAR LINERS

Catalog Number 960044000

Device Problems Disassembly (1168); Naturally Worn (2988)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Revision surgery is planned to replace the implanted j-loc 46mm x 28mm id 10 degree insert for a new device.Revision surgery will be done as soon as the customer specific device is available, the reason of the revision: insert loosening due to wear first surgery was done in 2006.Doi: 2006; unknown affected side.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Product complaint # :(b)(4).Investigation summary : depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: J-LOC 46MM X 28MM ID 10 DEGREE
• Type of Device: MISCELLANEOUS HIP CUP/LINER : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7592707
• MDR Text Key: 111053115
• Report Number: 1818910-2018-61956
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/17/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 960044000
• Device Lot Number: 2039224
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2018
• Initial Date FDA Received: 06/12/2018
• Supplement Dates Manufacturer Received: 07/27/2018
• Supplement Dates FDA Received: 08/09/2018
• Date Device Manufactured: 12/22/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention