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

Catalog Number UNK HIP FEMORAL STEM

Device Problem Loss of Osseointegration (2408)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); 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.(b)(4).

Event Description

The literature article entitled, "cementless bipolar hemiarthroplasty for low-energy intracapsular proximal femoral fracture in elderly east-asian patients: a longitudinal 10-year follow-up study" written by masanori nishi, md, ichiro okano, md, takatoshi sawada, md, natsuki midorikawa, md, and katsunori inagaki, md, phd published by hip & pelvis accepted by publisher 07-august-2019 was reviewed.The article's purpose was to assess long-term outcomes of cementless hemiarthroplasties (ha) in elderly east-asian patients with intracapsular proximal femoral fractured treated with cementless ha.Data was compiled from 135 patients and consisted of patients were alive and not alive (implant related deaths not reported within article) at 10 years post implantation.It is noted that only 3 depuy aml stems were utilized amongst non-depuy stems.The article does not clarify which adverse events are associated with specific product brands, and the article does not provide adequate information to determine accurate quantities.The article references "bipolar head" and therefore it is assumed that the depuy stems were utilized in conjunction with depuy bi-polar heads.Figures 1 and 3 provide radiographic images with patient identifiers but does not identify the implants (figure 1 a (b)(6) year old female with osteolysis 15 years post ha; figure 2 is the figure 1 patient who received revision with tha with narrative description providing details that revision was performed 15 years post ha due to bipolar head migration and painful osteolysis; figure 3 (b)(6) year old female with fracture after a fall 11 years post ha implantation).As the implant identity is not specified, the adverse events in radiographic images are captured within the listed adverse events.Depuy products: aml uncemented stem ("fully cylindrical and coated"), bi-polar femoral head (assumed).Adverse events: septic loosening (treated by revision).Dislocation (treated by closed reduction).Intraoperative fracture vancouver type a:3, c:1 (treated by cerclage wiring).Post operative vancouver type a and b1 (type a treated by conservative methods and type b1 internal fixation with a plate - also noted in figure 3).Figure 1 radiographically detected osteolysis on acetabulum (treated with revision with tha) and narrative description indicates associated pain.Figure 3 post operative vancouver type b1 periprosthetic fracture post fall (treated with orif).

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.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.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: 10061668
• MDR Text Key: 191138229
• Report Number: 1818910-2020-12186
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• 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: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention