MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ACS POLY 20D 28 GR2; ACS HIP LINERS : HIP POLY ACETABULAR LINERS

Model Number	1115-27-025
Medical Device Problem Codes	Difficult to Insert (1316); Off-Label Use (1494); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	05/20/2020
Type of Reportable Event	Malfunction
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
The patient undergo revision surgery due to poly wear that was reported in (b)(4).The liner would not lock into the cup.A second liner was then opened with the same result.The doctor determined that the locking mechanism had been compromised so he elected to cement a liner in place.Doe: (b)(6) 2020 right side.
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, post market surveillance, 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.H10 additional narrative:  corrected: h6 (device).

• Brand Name: ACS POLY 20D 28 GR2
• Common Device Name: ACS HIP LINERS : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10116937
• Report Number: 1818910-2020-13157
• Device Sequence Number: 2319715
• Product Code: HRY
• UDI-Device Identifier: 10603295004875
• UDI-Public: 10603295004875
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K944538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1115-27-025
• Device Catalogue Number: 111527025
• Device Lot Number: J10X12
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 07/16/2020
• 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; ACS POLY 20D 28 GR3; UNKNOWN HIP ACETABULAR CUP
• Patient Age: 61 YR