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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Fracture (1260); Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994); Pocket Erosion (2013); Inadequate Osseointegration (2646); Not Applicable (3189); No Code Available (3191)

Event Date 10/22/2009

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.(b)(4).

Event Description

"literature article entitled, ¿femoral revision hip arthroplasty: a comparison of two stem designs¿ by corey j.Richards md, masc, frcsc, et al, published by clinical orthopaedic related research (2010), vol, 468, pp.491-496, doi 10.1007/s11999-009-1145-7, was reviewed.In this article, the authors investigated whether the tfmt femoral components are better than cncc stems at achieving three important goals of revision hip arthroplasty: (1) improving quality of life; (2) avoiding complications; and (3) preserving or restoring femoral bone stock.The authors used a retrospective cross-sectional cohort comparison of 219 patients with one of two femoral component designs used for revision hip arthroplasty between january 2000 and march 2006.The authors previously reported the tfmt cohort results which was comprised of competitor components.The tfmt results are not included in this complaint.Depuy implanted products: 115 eligible patients who had cncc revision stems (solution; depuy).This retrospective study focused solely on femoral stems.The femoral head and acetabular component manufacturers are unknown.Results: 4 revisions for infection 4 revisions for aseptic loosening of the femoral stem 2 revisions for postoperative fracture of the femoral stem 29 instances of intraoperative femoral fracture- treatment unspecified 12 instances of unspecified instability- treatment unknown 26 cases of radiologically identified bone loss over 24 months follow-up there were reports of postoperative pain and stiffness form an unknown number of patients.The authors do not identify the need from intervention for pain or stiffness.Captured in this complaint: solution femoral stem".

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, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• 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, PA 46581-0988 ; 6107428552
• MDR Report Key: 9324364
• MDR Text Key: 182806959
• Report Number: 1818910-2019-115554
• Device Sequence Number: 1
• Product Code: KWA
• 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 STEM
• 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