MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

Device Problems Loss of or Failure to Bond (1068); Corroded (1131); Use of Device Problem (1670); Failure to Osseointegrate (1863); Migration (4003)

Patient Problems Unspecified Infection (1930); Osteolysis (2377); Inadequate Osseointegration (2646); No Code Available (3191)

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.

Event Description

06-sept-2019 literature article entitled: ¿fretting and corrosion damage in retrieved metal-on-polyethylene modular total hip arthroplasty systems: what is the importance of femoral head size?¿ by matthew p.Siljander, md, erin a.Baker, phd, *, kevin c.Baker, phd, meagan r.Salisbury, ms, clayton c.Thor, md, james j.Verner, md, published in the journal of arthroplasty 33 (2018) was reviewed for mdr reportability.The study¿s objective was to investigate associations among implant design, radiographic factors, and patient factors with corrosion and fretting at the taper interface in retrieved metal-on-polyethylene modular tha prostheses.The models of prostheses used include s-rom femoral stem and sleeve, aml femoral stem, summit femoral stem and hps ii femoral stem.All femoral heads were cobalt chromium alloy and of varying sizes, it is reasonable to conclude that the femoral heads used in conjunction with the depuy femoral stems would also be manufactured by depuy.Acetabular components manufacturer was not provided.The study identified the following to be adverse outcomes.It is not indicated what manufactured implants experienced what outcomes, therefore, all outcomes will be listed: infection, aseptic loosening, unspecified clinical failure, instability, periprosthetic fracture, ,osteolysis, ,femoral stem malpositioning, ,femoral stem subsidence, ,implant damage (femoral head fretting, femoral head corrosion, femoral stem trunnion fretting, femoral stem trunnion corrosion and femoral stem abrasion, pitting, burnishing, scratching), and revision / surgical intervention.

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.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. 1818910; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9128704
• MDR Text Key: 166019506
• Report Number: 1818910-2019-106318
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• 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
• Date Manufacturer Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention