MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DUR MAR 10D LINER 28IDX56OD; DURALOC IMPLANT : HIP POLY ACETABULAR LINERS

Model Number	1220-28-156
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Illegible Information (4050)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	02/17/2021
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
Revision of a depuy duraloc cup.Reason for revision was due to recurrent dislocation.56 cup was well fixed (unknown ref number and lot number).It was removed with the liner and a competitor cup was implanted.Head was also removed (unknown ref and lot number) and replaced with articuleze 9/10 elite femoral head.Stem was well fixed and was not removed.Unsure when the primary surgery was done.Right side.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: DUR MAR 10D LINER 28IDX56OD
• 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: 11398445
• Report Number: 1818910-2021-04093
• Device Sequence Number: 11067643
• Product Code: LPH
• UDI-Device Identifier: 10603295015192
• UDI-Public: 10603295015192
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K994415
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1220-28-156
• Device Catalogue Number: 122028156
• Device Lot Number: W4RES1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 04/29/2021; 05/04/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 05/03/2021; 05/05/2021
• 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 10D LINER 28IDX56OD; DURALOC CUP; UNK HIP BONE SCREW; UNK HIP BONE SCREW; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM; DUR MAR 10D LINER 28IDX56OD; DURALOC CUP; UNK HIP BONE SCREW; UNK HIP BONE SCREW; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR