MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Hematoma (1884); Myocardial Infarction (1969); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/20/2020

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

Article entitled ¿cementless hip revision cup for the primary fixation of osteoporotic acetabular fractures in geriatric patients" written by christopher a.Becker, christoph linhart, jan bruder, christian zeckey, axel greiner, adrian cavalcanti kubmaul, simon weidert, eduardo m.Suero, wolfgang böcker, christian kammerlander, published by orthopaedics & traumatology: surgery & research 107, aug 20, 2020 was reviewed.The aim of the present study was to determine (1) whether a therapeutic advantage could be achieved when using hip arthroplasty to treat acetabular fractures in geriatric patients; (2) whether an acetabular revision cup would be suitable for achieving fast postoperative mobilization and full weight-bearing; and (3) when a treatment with an uncemented hip revision cup for the primary fixation of osteoporotic acetabular fractures in geriatric patients is indicated.The functional outcome of tha using a reconstruction cup for an acetabular fracture was evaluated in ten patients using standardized scoring instruments.The presented research is an observational study of 10 patients who underwent total hip arthroplasty with a hip reconstruction cage for an acetabular fracture between 2016 and 2017 in the orthogeriatric unit of the university hospital of munich (lmu munich).Inclusion criteria were acetabular fracture, age > 60 years and documented osteoporosis.Competitor cup/liner were used in conjunction with depuy corail stem.For the purpose of this study, since the study did not report who manufactured the femoral head, it will be assumed that the femoral heads are depuy components and that the liners that fit in the competitor cup will be assumed to be competitor liners.Adverse events noted in the study: 2 patients suffered from urinary tract infections and delirium during the hospital stay.1 developed pneumonia.1 had a heart attack postoperatively.1 had postoperative heterotopic ossification of the gluteal musculature.1 hematoma was surgically resected.

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: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12390997
• MDR Text Key: 268889210
• Report Number: 1818910-2021-18949
• Device Sequence Number: 1
• Product Code: JDI
• 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: 08/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/07/2021
• Initial Date FDA Received: 08/31/2021
• Supplement Dates Manufacturer Received: 09/20/2021
• Supplement Dates FDA Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK HIP FEMORAL STEM CORAIL
• Patient Outcome(s): Required Intervention