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

Catalog Number UNK HIP FEMORAL STEM

Device Problem Corroded (1131)

Patient Problems Bone Fracture(s) (1870); No Code Available (3191)

Event Date 06/13/2013

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, " do ceramic femoral heads reduce taper fretting corrosion in hip arthroplast? a retrieval study" by steven m.Kurtz, phd, et al, published in clinical orthopaedics and related research by the association of bone and joint surgeons (13 june 2013) vol.471, pp.3270-3282 was reviewed for mdr reportability.The authors studied and compared evidence of fretting and corrosion observed on femoral stem tapers from 50 ceramic head stem and 50 cocr head-stem pairs retrieved after tha revision surgery over a 12-year period.All of the ceramic heads were produced by the same supplier- ceramtec and distributed by the manufacturers of each individual stem type.The biolx and biolox forte ceramic heads were used as well as the biolox delta ceramic heads manufactured by ceramtec.The ceramic-metal taper cohort include both cocmand copearings.The study included both cemented and uncemented components but found that the use of cement had no effect on the incidence of taper fretting or corrosion.The mop cohort used cocr femoral heads in a metal taper and the head was always cocr.In this study, the cocr heads were always the same manufacturer as the stem to eliminate manufacturer mixing as a confounding factor.None of the cocr heads included an inner modular taper adapter or sleeve.In this study, none of the revisions were performed as the result of an adverse local tissue reaction.In this study, there were many implants from a variety of manufacturers.The 14 individual patients with depuy implants are listed with adverse events and impacted products.The first seven cases are from the com taper cohort and patients 8-14 are from the mom cohort.The patient numbers are designated according to their identifiers within tables 1 and 2 on pages 3273-3276.All patients within the study experienced corrosion at the head/taper junction however, none of the revisions were due to that corrosion.The fretting and corrosion were identified by electron microscope after retrieval post-revision surgery.In the mom cohort, there was evidence or metal debris intraoperatively, there were no cases of metal debris in the com cohort.The authors concluded that there is a 5-11 fold increase in corrosion with a mom head-taper than there is with a com head-taper junction.The authors found that the only patient indicator of increased likelihood of corrosion was a higher patient bmi.Please refer to the individual case reports for specific events related to depuy components and their associated patient codes.(b)(6)-year-old female, bmi 21, 28-mm cocr femoral head with 64-mm offset, corail ti alloy stem with 12/14 taper, periprosthetic fracture 5.2 years after index tha.

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.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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 46582 0988
• MDR Report Key: 8969479
• MDR Text Key: 161520241
• Report Number: 1818910-2019-103268
• 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: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2019
• 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: 09/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR