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

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Fracture (1260); Loss of Osseointegration (2408)

Patient Problems Bone Fracture(s) (1870); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Renal Failure (2041); Inadequate Osseointegration (2646); 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.

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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #: (b)(4).Investigation summary: no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8792823
• MDR Text Key: 151105560
• Report Number: 1818910-2019-98210
• 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,literature
• 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: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BONE CEMENT; UNKNOWN BONE CEMENT
• Patient Outcome(s): Required Intervention