MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DURALOC CONST LINER 56/68X32; DURALOC IMPLANT : HIP POLY ACETABULAR LINERS

Model Number	1242-16-527
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/05/2021
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
On (b)(6) 2021 surgeon removed a duraloc constrained liner, a duraloc dynamic locking ring, and a total hip ball femoral head.These were replaced with identical new components.Reason for revision: dislocation.The large metal locking ring which is usually constrained within the liner had completely popped out of the liner itself.X-rays and other operative notes unavailable.
Event or Problem Description
Additional information received indicated that there was no surgical delay.
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.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 a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

• Brand Name: DURALOC CONST LINER 56/68X32
• 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: 11857374
• Report Number: 1818910-2021-10829
• Device Sequence Number: 11027403
• Product Code: KWZ
• UDI-Device Identifier: 10603295019206
• UDI-Public: 10603295019206
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P960054
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

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: 1242-16-527
• Device Catalogue Number: 124216527
• Device Lot Number: H29382
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 06/15/2021
• 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: CREATED IN ERROR.; DUR DYNAMIC LOCK RING 56 OR 68; DURALOC CONST LINER 56/68X32; TOTAL HIP BALL 32MM +11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR