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

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Corroded (1131); Degraded (1153); Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Tissue Damage (2104); No Code Available (3191)

Event Date 06/24/2014

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).(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, ¿adverse local tissue reactions in metal-on-polyethylene total hip arthroplasty due to trunnion corrosion: the risk of misdiagnosis¿ by m.R.Whitehouse, et al, published by the bone and joint journal (2015), vol, 97-b, pp.1024-1030, doi:10.1302/0301-620x.97b8, was reviewed.The authors performed a detailed review of 17 consecutive metal-on-highly cross-linked polyethylene (mop) thas with a histopathologically confirmed pseudotumor associated with corrosion of the trunnion at the head¿neck junction.The purpose of the review was to highlight the risk of misdiagnosis in this cohort and support efforts to refine the accurate diagnosis of pji.This article contains 17 individual case studies.Of these 17 cases, only patient 4 and patient 14 had depuy products including a prodigy stem and a depuy femoral head.The remaining case studies were implanted with competitor products and are not included in this study.The indications for revision and intraoperative findings are detailed in the individual case event descriptions.In this complaint, case 1 patient #4 is included on the parent (b)(4).Case 2 patient # 14 is included on the attached guidance document and linked to this parent pc.Implants captured in this complaint: prodigy femoral stem and unknown femoral head." (b)(6) male implanted with a depuy prodigy stem, unk 36-mm depuy femoral head, and competitor acetabular components.Revised 64 months after index tha for histopathologically confirmed pseudotumor, pain, periarticular fluid with inflammatory markers, and unspecified instability.Corrosion of the trunnion on the taper junction of both the head and stem.There is insufficient evidence within the article to determine which products were revised.All histopathologic identifications were confirmed intraoperatively.There was gross evidence of bearing wear on the femoral head.There was evidence of soft tissue damage identified intraoperatively.

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 46581-0988 ; 6103142063
• MDR Report Key: 9325556
• MDR Text Key: 184993847
• Report Number: 1818910-2019-115547
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• 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: 12/11/2019
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR