MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK CABLE/WIRE

Catalog Number UNK CABLE/WIRE

Device Problem Fracture (1260)

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 ago 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.No further information is available.

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: UNK CABLE/WIRE
• Type of Device: UNK CABLE/WIRE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11745121
• MDR Text Key: 247942724
• Report Number: 1818910-2021-09186
• Device Sequence Number: 1
• Product Code: JDQ
• 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: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK CABLE/WIRE
• Date Manufacturer Received: 06/07/2021
• Patient Sequence Number: 1
• Treatment: 9/10 COCR HEAD 22.225MM -3; CB DURALOC 10DEG LINER 48MM; UNK CABLE/WIRE; UNKNOWN HIP ACETABULAR CUP; 9/10 COCR HEAD 22.225MM -3; CB DURALOC 10DEG LINER 48MM; UNK CABLE/WIRE; UNKNOWN HIP ACETABULAR CUP
• Patient Outcome(s): Required Intervention