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

Catalog Number UNK HIP FEMORAL STEM

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Unspecified Infection (1930); Pain (1994); No Code Available (3191)

Event Date 03/01/2010

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

The literature article entitled, "no differences in outcomes between cemented and uncemented acetabular components after 12-14 years: results from a randomized controlled trial comparing duraloc with charnley cups" written by kristian bjorgul, wendy m.Novicoff, s.T.Andersen, k.Brevig, f.Thu, m.Wiig, and o.Ahlund published by journal orthopaedics traumatol (2010) 11: 37-45 doi 10.1007/s10195-010-0082-2 was reviewed for mdr reportability.The articles reports upon results of a comparitive study of 240 hips enrolled who received implants between april 1994 and june 1997.The hips contained cemented depuy charnley stems and the uncemented acetabular group contained depuy duraloc cups with enduron poly liners while the cemented acetabular group contained depuy charnley cups with all-polyethylene cups with flange (ogee cup used in 101 cases and low posterior wall cup in 19 cases.) the article reports 31 femoral revisions were performed but does not provide reasons.The article further reports 13 cups (9 in charnley group and 4 in duraloc group) were revised total: loosening (3 charnley), dislocation (1 charnley), and prosthetic infection (5 charnley); the duraloc cups were revised in conjunction with femoral stem revisions and one removed during revision for instability but not found to be loose.The articles notes: "there were no isolated exchanges of liner, but the liner was changed en passant in conjunction with femoral revision).Patients who experienced dislocations were treated by closed reduction (4) and 1 of these did receive revision due loosening of femoral component.Antibiotics were given for various types of infections and it is noted that the high rate of infection in charnley group revealed that mean operating time was longer in the infected group with older patients verse patients who did not become infected.The article does not provide product information on cement utilized for femoral stems.Adverse events: surgical intervention, infection, charnley femoral stem loosening, charnley cup loosening.

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.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.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 46582 0988
• MDR Report Key: 9111946
• MDR Text Key: 164403870
• Report Number: 1818910-2019-106012
• 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: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• 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