MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DUR MAR NEUT LINER 28IDX50OD; DURALOC IMPLANT : HIP POLY ACETABULAR LINERS

Model Number	1220-28-050
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	08/05/2021
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
It was reported that the patient was subluxing.Surgeon removed cup and head then put in a zb dual mobility implant.Pt had a duraloc cup and aml stem done in (b)(6) sometime ago.The doctor did not have a date for me.No surgical delay.Doi: unknown, 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.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.
Event or Problem Description
Additional information received indicated that the cup was removed due to malposition.The head had worn the poly down over time.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: DUR MAR NEUT LINER 28IDX50OD
• 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: 12362683
• Report Number: 1818910-2021-18545
• Device Sequence Number: 19791796
• Product Code: LPH
• UDI-Device Identifier: 10603295015062
• UDI-Public: 10603295015062
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/05/2021

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: 1220-28-050
• Device Catalogue Number: 122028050
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 09/02/2021; 09/13/2021
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 09/09/2021; 09/15/2021
• 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: ARTICUL/EZE BALL 28 +1.5 GR; CANCELLOUS BONE SCREW 6.5X30MM; DUR MAR NEUT LINER 28IDX50OD; DURALOC DYNAMIC LOCK RING 50MM; DURALOC SECTOR SERIES 50OD; ARTICUL/EZE BALL 28 +1.5 GR; CANCELLOUS BONE SCREW 6.5X30MM; DUR MAR NEUT LINER 28IDX50OD; DURALOC DYNAMIC LOCK RING 50MM; DURALOC SECTOR SERIES 50OD
• Outcome Attributed to Adverse Event: Required Intervention