MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 CB DURALOC 10DEG LINER 48MM; DURALOC IMPLANT : HIP POLY ACETABULAR LINERS

Catalog Number 123948500

Device Problem Difficult to Remove (1528)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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 that about 20 years before now, on an unknown date, the primary surgery was performed via tha with the liner, head and wire in question.On an unknown date, it was confirmed that the wire, which was used around the femur, had been broken, and the pus was spreading, and the patient felt pain due to this event on the right side.On (b)(6) 2021, the revision surgery will be performed replacing the liner and head.On (b)(6) 2021, the revision surgery was performed.Before entering the room, the patient was already bleeding at her femoral shaft part, and her femur was covered with gauze.After the surgeon made an incision, he cut the cables and removed them with a pliers.And he removed the head and tried to remove the liner, but he had difficulty in removing the liner with the removal instruments.Finally, he broke the liner with a chisel and remove the liner.He implanted new head and liner and closed the incision.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: CB DURALOC 10DEG LINER 48MM
• Type of Device: DURALOC IMPLANT : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 11723825
• MDR Text Key: 247255377
• Report Number: 1818910-2021-08648
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/04/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 123948500
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/04/2021
• Initial Date FDA Received: 04/26/2021
• Supplement Dates Manufacturer Received: 06/07/2021
• Supplement Dates FDA Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 9/10 COCR HEAD 22.225MM -3; UNK CABLE/WIRE; UNKNOWN HIP ACETABULAR CUP; 9/10 COCR HEAD 22.225MM -3; UNK CABLE/WIRE; UNKNOWN HIP ACETABULAR CUP
• Patient Outcome(s): Required Intervention