MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

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

Patient Problems Sepsis (2067); Osteolysis (2377); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary.No device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.(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, ¿a comparison of acetabular impaction grafting and trabecular metal for revision arthroplasty¿ by fiachra e.Rowan, et al, published by hip international (2016), vol, 26, no.4, pp.350-354, doi: 10.5301/hipint.5000362, was reviewed.In this retrospective comparative case-control series, the authors compare acetabular impaction bone grafting (aibg) and trabecular metal (tm) acetabular reconstruction from a single institution over a 5- to 10-year period.The aim was to determine any significant difference in radiological or clinical outcomes between both acetabular surgical revision strategies.This article focuses on acetabular reconstruction during competitor cup revision.Implanted products: the initial implants for thas were a competitor cup and liner with a charnely femoral component.If a concomitant femoral revision was indicated, either a depuy nonmodular solution stem or a depuy modular reclaim system was used.There were 2 revisions of an asr hra included within the study, assigned to the impaction bone grafting group.The reasons for cup revision included acetabular osteolysis and sepsis (4 cases).There was one periprosthetic fracture for a charnley stem that was revised.The remaining reasons for charnley stem revision (33) were unspecified instability, femoral osteolysis, and sepsis.The femoral osteolysis is attributed to the competitor polyethylene liner.Implanted products at revision were a competitor cup and liner and a depuy stem and head.Revision results: this article discusses the outcomes of revision for competitor cups and liners and will therefore not be included in this complaint.Of the stems and heads revised, 1 needed resection arthroplasty for sepsis and another was revised at another institution for unknown reasons.Captured in this complaint: 1 asr hemiarthroplasty for osteolysis and sepsis.33 charnley stems for sepsis, and unspecified instability.The authors do not attribute the joint instability to a specific product or location.The osteolysis listed in the article is attributed to the competitor polyethylene liner.33 depuy femoral heads for sepsis, and unspecified instability.The authors do not attribute the joint instability to a specific product defect or location.The osteolysis listen in the article is attributed to the competitor polyethylene liner.1 femoral stem, head, and sleeve re-revised for sepsis.1 femoral stem, head, and sleeve re-revised for unknown causes.The authors provide information on page 353 in fig, 1 regarding and asr hemiarthroplasty revised for sepsis.This complaint is labeled case 1 in the guidance document.Please link that complaint to parent (b)(4).".

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9267226
• MDR Text Key: 184815135
• Report Number: 1818910-2019-111036
• Device Sequence Number: 1
• Product Code: KXA
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: Yes
• 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: 10/11/2019
• 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
• Patient Outcome(s): Required Intervention