MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ACS POLY 20D 28 GR3; ACS HIP LINERS : HIP POLY ACETABULAR LINERS

Model Number 1115-28-025

Device Problems Difficult to Insert (1316); Off-Label Use (1494); Device-Device Incompatibility (2919)

Patient Problem Not Applicable (3189)

Event Date 05/20/2020

Event Type  malfunction  

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 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.

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 GR3
• Type of Device: ACS HIP LINERS : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10116939
• MDR Text Key: 193995120
• Report Number: 1818910-2020-13158
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 10603295004899
• UDI-Public: 10603295004899
• Combination Product (y/n): N
• PMA/PMN Number: K944538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1115-28-025
• Device Catalogue Number: 111528025
• Device Lot Number: 688371
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACS POLY 20D 28 GR2; ACS POLY 20D 28 GR3; UNKNOWN HIP ACETABULAR CUP
• Patient Age: 61 YR