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

Model Number	1220-28-048
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Off-Label Use (1494)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/26/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: DURALOC IMPLANT : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11962585
• Report Number: 1818910-2021-12193
• Device Sequence Number: 3675098
• Product Code: LPH
• UDI-Device Identifier: 10603295015055
• UDI-Public: 10603295015055
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K994415
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 1220-28-048
• Device Catalogue Number: 122028048
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DUR MAR NEUT LINER 28IDX48OD; TOTAL HIP BALL 28MM +8; UNKNOWN HIP ACETABULAR CUP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR