MAUDE Adverse Event Report: DEPUY INT'L LTD. 8010379 UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Nonstandard Device (1420); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2006

Event Type  malfunction  

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.(b)(4).

Event Description

"literature article entitled, ¿hip resurfacing: why does it fail? early results and critical analysis of our first 60 cases¿ by f.Falez, et al, published by international orthopaedics (2008), vol.32, pp.209-216, was reviewed.The aim of this prospective study was to evaluate early implant behavior of mom hip resurfacing prostheses by analyzing the mechanisms of failure and related risk factors as these represent critical items in terms of the increased impact of an early revision in a young patient population.The authors focus of the study was mom hemiarthroplasty implants from various manufacturers.The preoperative diagnoses for the patients in this study were post-traumatic osteoarthritis, avascular necrosis of the femoral head, and femoral dysplasia such as an extremely short femoral neck.Implanted products: the authors used mom hip resurfacing implants from 4 different manufactures.The depuy product included in the study was the asr resurfacing system.In all cases the cup was cementless and the femoral head component was cemented.The manufacturer of the cement was unknown.Results: the authors grouped the results from each manufacturer into one report.There was no information provided to differentiate the revisions and complications by manufacturer.The following results are for the entire study.1 revision for femoral neck fracture.2 revisions for loosening of the femoral head caused by osteolysis.1 revision for pain caused by osteolysis.6 radiographically identified mispositioned femoral heads requiring no revision.2 radiographically identified loose femoral heads with osteolysis.These patients were no recommended for revision and were being monitored at final follow-up.2 implants are being monitored for unexplained pain, no revision recommended at final follow-up.1 instance of a ¿stiff joint¿ being monitored, no revision surgery recommended at final follow-up.The authors note that the complications in this study had a causal correlation to the cement used to secure the femoral component due to penetration of the cement into the femoral neck.Any complications directly attributed to the unknown cement are not included in this complaint.The osteolysis identified in this study was confirmed intraoperatively or by serial radiographs performed during the follow-up period.Captured in this complaint: asr hemiarthroplasty.".

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INT'L LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9321617
• MDR Text Key: 186731013
• Report Number: 1818910-2019-116039
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2019
• 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
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1