MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS

Catalog Number UNK HIP ACETABULAR LINER

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Renal Failure (2041); Joint Dislocation (2374); Thromboembolism (2654); No Code Available (3191)

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. [(b)(4)].

Event Description

On 23-june-2019 literature article entitled: ¿early failure of the ultima metal-on-metal total hip replacement in the presence of normal plain radiographs¿. The study¿s objective was to review the results of the use of the ultima hybrid metal-on-metal total hip replacement. The models of prostheses used include ultima hybrid metal-on-metal total hip replacement, with a cemented polished tapered femoral component with a 28 mm diameter and a cobalt-chrome (cocr) modular head, articulating with a 28 mm cocr acetabular bearing surface secured in a titanium alloy uncemented shell. Please note, it is indicated that the shell utilized has 3 screw holes for further fixation. Cement is indicated to be competitor. The study identified the following to be adverse outcomes, patient quantity is stated if provided: 90 revision / surgical intervention. 33 loosening of the stem, acetabular component or both. 23 renal impairment. 19 dislocation. 17 periprosthetic fractures. 15 venous thromboembolism. 9 infection. 9 persistent wound leakage. 4 squeaking / clunking. 2 palpable masses because of collections of fluid. 1 implant fracture. 1 iliotibial band defect. 1 late palsy of the sciatic nerve ¿ permanent. 1 chronic renal failure. Pain. Cloudy fluid within joint cavities. Necrotic soft tissues with avulsed tendons. Denuded osteonecrotic upper femora. Metal debris / metal wear / metal within surrounding tissue. Reaction to metal debris / histological evidence of hypersensitivity. Corrosion.

• Brand Name: UNKNOWN HIP ACETABULAR LINERS
• Type of Device: HIP ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380-0988 ; 6103142063
• MDR Report Key: 8792826
• MDR Text Key: 151106040
• Report Number: 1818910-2019-98207
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: UNK HIP ACETABULAR LINER
• 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: 09/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/16/2019 Patient Sequence Number: 1

Treatment

UNKNOWN BONE CEMENT