MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER POLY

Catalog Number UNK HIP ACETABULAR LINER POLY

Device Problem Naturally Worn (2988)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 05/10/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (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

Literature article entitled "fourth generation head fracture in ceramic-on-polyethylene bearing after hip revision surgery: a case report" written by roberto valentini, andrea vacchiano, andrea sandri, dario regis, carlo dall¿oca, bruno magnan published by acta biomed published online/accepted by publisher 10 may 2020 was reviewed. The article's purpose was to examine fourth generation ceramic bearings which were developed to reduce wear debris and improve fracture resistance. The case study examines a fourth generation head fracture in ceramic-on-polyethylene coupling with subsequent revision. Data was compiled from a case study involving one patient. Computer tomography scans can be found on page 3 of the case study. Implant images and x-ray images can be found on page 4 of the case study. Adverse events: the patient underwent a right hip revision due to pain, decreased range of motion, implant fracture of the ceramic femoral head, and poly wear of the acetabular liner. The acetabular cup and femoral stem were both well-fixed and retained.

• Brand Name: UNK HIP ACETABULAR LINER POLY
• Type of Device: ACETABULAR LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 11049498
• MDR Text Key: 223064790
• Report Number: 1818910-2020-27383
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (Y/N): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: FOREIGN,HEALTH PROFESSIONAL,L
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Type of Report: Initial
• Report Date: 12/10/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 12/21/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: UNK HIP ACETABULAR LINER POLY
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/10/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 12/21/2020 Patient Sequence Number: 1