MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DURALOC 300 SERIES 54MM OD; DURALOC IMPLANT : HIP METAL ACETABULAR CUPS

Catalog Number 124654000

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 09/01/2020

Event Type  Injury  

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

It was reported by the surgeon that the patient had a dislocation of the femoral head from the duraloc constrained acetabular liner.The duraloc acetabular shell, liner, and the femoral head were revised to a pinnacle shell with a 40id liner and femoral head.No surgical delay noted.Doi: 2004.Dor: (b)(6) 2020; right hip.

Event Description

Additional information received indicated that the constraining ring of the constrained liner was off, disassociated, and was noted to be hanging around the neck of the stem as per the provided x-rays.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Through examination of the provided x-ray images it is possible to confirm the cup is not positioned as is recommended by depuy.Cup position is determined by the implanting surgeon and is not considered a product problem.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.Concomitant liner information is to large to submit in concomitant section.

• Brand Name: DURALOC 300 SERIES 54MM OD
• Type of Device: DURALOC IMPLANT : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10636482
• MDR Text Key: 210043297
• Report Number: 1818910-2020-21638
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K951301
• 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: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 124654000
• Device Lot Number: 1130612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 32MM +5 CERAMIC TS HEAD 12/14 ARTICULEZE; DURALOC 300 SERIES 54MM OD; LOCKING RING; 32MM +5 CERAMIC TS HEAD 12/14 ARTICULEZE; DURALOC 300 SERIES 54MM OD; LOCKING RING
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR