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

Catalog Number UNK HIP FEMORAL STEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Bone Fracture(s) (1870); Pain (1994); No Code Available (3191)

Event Date 10/13/2019

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.

Event Description

The literature article entitled, "the fate of sagittal alignment in tapered uncemented femoral components in total hip arthroplasty: 889 hips followed for a minimum of 10 years" written by eduardo garcia-rey published by hip international accepted by publisher on 13 october 2019 was reviewed.The article's purpose was to discover whether 3 different current femoral components and/or the surgical technique affect the clinical and radiological outcome after a minimum follow-up of 10 years.Data was compiled from 889 uncemented tapered stems implanted from 1999 to 2007 separated into 3 groups based upon the stem type.Group 1 contained depuy summit stem (ha coated), duraloc cup with poly liner and 28 mm metal femoral head.The other two groups contained non depuy products.It is noted that no stems were revised.Figure 1a, 2a, 3a provides radiographic images of summit stems for illustrative purposes.Depuy products: summit stem, duraloc cup, poly liner, metal head.Group 1 adverse events: intraoperative femur fractures (treated by cerclage wiring).Dislocations (treated by revision of head, liner, and some required cup revision - no further details provided).Postop periprosthetic femur fracture (treated by revision).Osteopenia (radiographically detected without indication of treatment).General reports of pain.Pedestal at end of follow up (radiographically detected without indication of treatment).Proximal osteolysis (no indication of treatment).

Manufacturer 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 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.

• 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: 10592342
• MDR Text Key: 208718602
• Report Number: 1818910-2020-20967
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 09/22/2020

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: 09/22/2020
• Initial Date FDA Received: 09/28/2020
• Supplement Dates Manufacturer Received: 10/20/2020
• Supplement Dates FDA Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention