MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 46X28 BRN HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Catalog Number 103546000

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/02/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4). Investigation summary: examination of the returned device components is unable to confirm the reported problem. The components can be assembled as intended with no excess movement. 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. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the polyethylene liner is toggling within the bipolar head right out of the package.

• Brand Name: SELF CENT HIP 46X28 BRN
• Type of Device: HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380 ; 6107428552
• MDR Report Key: 8270473
• MDR Text Key: 133849783
• Report Number: 1818910-2019-81953
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 10603295003366
• UDI-Public: 10603295003366
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K812672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/02/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 103546000
• Device Lot Number: J1239F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/02/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 10/29/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial