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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Examination of the attached images could not confirm the reported complaint.A root cause could not be determined.The information received will be retained for potential series investigations if triggered by trend analysis 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.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.Corrected: e1 (country code).

• 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
• 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
• Type of Report: Initial,Followup
• 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
• Date Manufacturer Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention