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); Fitting Problem (2183); Loss of Osseointegration (2408)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Test Result (2695); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).(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, ¿revisions of metal-on-metal hip resurfacing: lessons learned and improved outcome¿ by koen a.Se smet, md, published by orthopedic clinics north america (2011), no.42, pp.259-269, was reviewed.The aim of this retrospective, consecutive case series of a single surgeon was to assess the outcome following revision of mom hemiarthroplasties.In addition, the authors assessed whether the lessons learned from the initial previously reported experience improved outcome, and whether screening with the use of metal ions had an effect on post-revision outcome.This complaint captures the revised depuy mom components.The products used at revision are unknown.Implanted products: 10 asr hemiarthroplasties (cup and head) and 2 asr xl thas (cup, head, augment).The remainder of the 113 hips studied were from competitor products.Results: the results of this study were not separated by product and/or manufacturer.This complaint will capture all reported reasons for revision surgery and intraoperative findings.57 cup malpositioning.15 cup loosening.11 head misposition.21 head loosening.57 osteolysis (acetabular and femoral).6 periprosthetic femur fractures.6 infections.40 elevated blood heavy metal.Mean co 22.42 ppb and mean cr 22.39 ppb.Intraoperative findings: osteolysis, unspecified impingement, oversized components (unspecified components and locations), metallosis, metal debris, hypersensitivity (pseudotumor), and soft tissue fluid collections, and ground swelling.There were six instances of femoral component loosening attributed to pseudotumor formation.The authors found significant wear on the bearing surfaces intraoperatively.Only 4 patients requiring surgery reported no pain.This complaint captures all adverse events and intraoperative findings listed within the article.The authors do not specify which product or manufacturer is associated with each event.Included within this complaint: 1 asr hemiarthroplasty (head and cup) and 1 ars-xl (head, cup, augment).The implants used in the revision surgery were competitor products and are therefore not captured within this complaint.The authors provide radiographic evidence and patient identifiers for one patient having an asr hemiarthroplasty revised.This information is captured on the attached guidance document and should be linked to parent (b)(4)." this pc contains one additional pc to capture a single case study within the article labeled (b)(6) female.Please link the additional pc to the parent (b)(4).This complaint is for the asr hemiarthroplasty.

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.Product complaint # (b)(4).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 code(s) 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.Corrective action was not indicated.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: 9256220
• MDR Text Key: 178272377
• Report Number: 1818910-2019-113092
• Device Sequence Number: 1
• Product Code: KWA
• 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: 10/07/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/07/2019
• Initial Date FDA Received: 10/30/2019
• Supplement Dates Manufacturer Received: 11/04/2019
• Supplement Dates FDA Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention