MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ACS POLY 20D 28 GR2; ACS HIP LINERS : HIP POLY ACETABULAR LINERS

Model Number	1115-27-025
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 had a worn acs liner.The original surgery was done 25 years ago by the surgeon.There was a liner exchange sometime between the original surgery and this poly exchange.The poly that was removed had some wear but had not yet failed.We replaced with the same poly liner as the last exchange.The case went perfectly.Doi: approx 10 years ago; dor: (b)(6) 2020; right 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.H6 patient code: no code available (3191) was used to capture insufficient information.

• Brand Name: ACS POLY 20D 28 GR2
• Common Device Name: ACS HIP LINERS : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10105743
• Report Number: 1818910-2020-12927
• Device Sequence Number: 908326
• Product Code: KWA
• UDI-Device Identifier: 10603295004875
• UDI-Public: 10603295004875
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2020

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: 1115-27-025
• Device Catalogue Number: 111527025
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2020
• Supplement Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 06/01/2020
• Supplement Report FDA Received Date: 07/10/2020
• 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: ACS POLY 20D 28 GR2; TOTAL HIP BALL 28MM +3; ACS POLY 20D 28 GR2; TOTAL HIP BALL 28MM +3
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR