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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problems Pain (1994); Pocket Erosion (2013); Sepsis (2067); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 03/21/2005

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, ¿fractures of distally-fixed femoral stems after revision arthroplasty¿ by c.A.Busch, et al, published by the journal of bone and joint surgery (october 2015), vol.87-b, no.9, pp.1333-1336, was reviewed.In this article, the authors retrospectively reviewed 219 revision surgeries of 151 depuy solution and 68 competitor femoral stems to evaluate for the incidence of and factors associated with postoperative stem implant fracture.The authors do no not provide information regarding the manufacture of the cups, heads, and liners used in the revision surgery.Any indication for revision attributed to the unknown components will not be included in this complaint.Implanted depuy products: 151 solution stems reasons given for revision surgery: with the exception of the stem fractures, the authors do not differentiate reasons for revision with component manufacturer.5 postoperative stem fractures, 2 depuy solution stems and 3 competitor stems.The factors associated with stem fatigue fracture were deficient proximal femoral bone stock, a bmi > 30, trochanteric osteotomy during revision surgery, and a femoral component with a diameter less than 35.32 revisions for femoral periprosthetic fracture 33 revisions for sepsis 3 revisions for unspecified pain 2 revisions for unspecified instability 135 revisions for aseptic loosening 15 cases of absent cancellous femoral bone and cortical tube as well as 46 cases of deficient cancellous femoral bone and cortical tube confirmed during stem removal.The bone loss was not listed as a reason for revision.The authors provide detailed information for the patients who experiences femoral stem fracture.The two device fractures are labeled case 1 and case 2 in the attached guidance document.The parent pc-000579854 includes the reasons for revision that are not associated with stem fracture.The reasons for revision not attributed to unknown acetabular components and femoral heads are not included in this complaint.Captured in this complaint: 151 solution femoral stem revisions for: sepsis, fracture post-op, implant loosening: implant to bone, instability, inadequate osseointegration, pain, medical device site erosion.Surgical intervention, medical device removal.

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).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 46581 0988
• MDR Report Key: 9324876
• MDR Text Key: 182473031
• Report Number: 1818910-2019-114017
• 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: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• 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: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention