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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Loss of or Failure to Bond (1068); Fracture (1260)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Injury (2348); Osteolysis (2377); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 03/03/2014

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, ¿comparing the long-term results of two uncemented femoral stems for total hip arthroplasty¿ by stephen m.Petis, md, et al, published by the journal of arthroplasty (2015), vol.30, pp.781-785, was reviewed.The purpose of this study was to 1) determine if there is a difference in survivorship across two different cementless femoral stems, and 2) are clinical and radiographic outcomes similar at long-term follow-up.The authors retrospectively reviewed all patients who had a total hip arthroplasty using either a proximally coated cementless stem (competitor product) or extensively coated cementless stem (prodigy, depuy) between 1996 and 2002.Implanted products: prodigy stem, 185 duraloc cups, 185 depuy polyethylene liners, 179 articul/eze and 6 biolox forte femoral heads.Results: 4 prodigy stem revisions: 2 for stem fractures post-op, 1 for aseptic loosening, 1 for periprosthetic femur fracture post-op.5.3% reported thigh pain.17.7% reported severe stress shielding of the femur.31 cases of pedestal formation.22 liner revisions for polyethylene wear.3 acetabular component revisions (unspecified) for joint instability.3 cup revisions for acetabular osteolysis and/or aseptic loosening of the cup.There were no further complications listed within the text.".

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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: 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 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: 9243142
• MDR Text Key: 177007799
• Report Number: 1818910-2019-108620
• 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: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/04/2019
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 11/18/2019
• Supplement Dates FDA Received: 11/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention