MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DUR MAR NEUT LINER 28IDX48OD; DURALOC IMPLANT : HIP POLY ACETABULAR LINERS

Model Number 1220-28-048

Device Problems Loss of or Failure to Bond (1068); Off-Label Use (1494)

Patient Problem Pain (1994)

Event Date 05/26/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).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 the patient had cemented poly liner and femoral head replaced during revision due to pain.Cemented poly liner was found to be loose inside acetabular cup.Revised with another cemented poly inside the acetabular component and a new femoral head.No further information available.Doi: (b)(6) 2018 dor: (b)(6) 2021 left hip.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary : no device associated with this report was received for examination.Use of a cement product to place this liner within a depuy cup is considered off-label use.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.Device history lot : a device history record (mre) review, was not possible because the required lot code was not provided.

• Brand Name: DUR MAR NEUT LINER 28IDX48OD
• 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: 11962585
• MDR Text Key: 255074493
• Report Number: 1818910-2021-12193
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295015055
• UDI-Public: 10603295015055
• 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: 05/26/2021

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 Model Number: 1220-28-048
• Device Catalogue Number: 122028048
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/26/2021
• Initial Date FDA Received: 06/08/2021
• Supplement Dates Manufacturer Received: 07/06/2021
• Supplement Dates FDA Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DUR MAR NEUT LINER 28IDX48OD; TOTAL HIP BALL 28MM +8; UNKNOWN HIP ACETABULAR CUP
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR