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

Catalog Number UNK HIP FEMORAL STEM

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

Patient Problems Bone Fracture(s) (1870); Thrombosis (2100); Injury (2348); Post Operative Wound Infection (2446); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Article and guidance document attachments are too large for medwatch submission.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The literature article entitled, "cementless femoral revision arthroplasty 2 to 5 year results with a modular titanium alloy stem" written by jason a.Smith, md, harold k.Dunn, md, and b.J.Manaster, md published by the journal of arthroplasty vol.12 no.2 1997 was reviewed.The article's purpose was to review the results of a consecutive series of cementless femoral revisions that were followed prospectively.Data was compiled from revision surgeries between october 1988 to december 1991 with 35 male and 31 female patients with average age at time of surgery of 64.5 years.It is noted that the only depuy product utilized with srom femoral stem and all other components were non-depuy used in conjunction with the srom stem.The article reports generalized outcomes/adverse events and also identifies 2 patients with identifiers in radiographic images that are captured individually in linked complaints.Depuy products utilized: srom stem.This complaint captures the generalized adverse events: pain (no interventions clarified), radiographic findings of decreased femur bone density (no interventions clarified), intraoperative fractures in proximal and distal parts of femur during implantation (treated with cerclage wiring), intraoperative fractures caused by reamer (treated with cerclage wiring), post-op femur "secondary to fall" (no interventions clarified), dvt (no interventions clarified), vascular injury (no interventions clarified), exacerbation of congestive heart failure(no interventions clarified), peroneal nerve palsy(no interventions clarified), and superficial wound infection(no interventions clarified).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: corrected: h6 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 - null.Device history batch - null.Device history review - null.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
• MDR Report Key: 9416802
• MDR Text Key: 185203110
• Report Number: 1818910-2019-120742
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention