MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DUR MAR +4 LINER 28IDX58OD; DURALOC IMPLANT : HIP POLY ACETABULAR LINERS

Catalog Number 122028458

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199)

Event Date 06/15/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Usfda mdr determination: it is reasonable to conclude that the acetabular cup, femoral stem components would not have caused or contributed to the needed revision as the surgeon elected not to revise them.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that a painful right hip and head liner exchange.No additional information.No surgical delay.

Manufacturer 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 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.

• Brand Name: DUR MAR +4 LINER 28IDX58OD
• Type of Device: DURALOC IMPLANT : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10200322
• MDR Text Key: 196595125
• Report Number: 1818910-2020-14506
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K994415
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/15/2020

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: 122028458
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/15/2020
• Initial Date FDA Received: 06/26/2020
• Supplement Dates Manufacturer Received: 08/07/2020
• Supplement Dates FDA Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 80