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

Catalog Number UNK HIP FEMORAL STEM

Device Problem Use of Device Problem (1670)

Patient Problems Hemorrhage/Bleeding (1888); Hip Fracture (2349); No Code Available (3191)

Event Date 12/26/2016

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, "conversion hip arthroplasty in failed fixation of intertrochanteric fracture: a propensity score matching study" written by young-kyun lee, md, jung taek kim, md, awad abdalla alkitaini, md, ki-choul kim, md, yong-chan ha, md, and kyung-hoi koo, md published by the journal of arthroplasty 32 (2017) 1593-1598 published online 22 december 2016 was reviewed.The article's purpose: "to determine whether there were differences in the type of arthroplasty, operative parameters, perioperative morbidity, 1-year mortality, and postoperative outcome between conversion hip arthroplasty due to fixation failure and primary hip arthroplasty in intertrochanteric fracture." data was compiled from 33 patients (33 hips with mean age of 74.1 years and mean interval between internal fixation and conversion tha of 11 months with procedures performed october 2003 and march 2015 for each group (conversion group and control group).Depuy products utilized in conversion group: kar stem (6), corail stem(1), pinnacle cup (1).All other components were non-depuy in this group.Depuy products utilized in control group: kar stem (10), corail stem (3), pinnacle cup (3).All other components were non-depuy in this group.Adverse events: blood transfusion (range between 500-1800 ml total), stem malposition, postoperative periprosthetic fracture of femur treated with open reduction and internal fixation, heterotopic ossification.The article does not identify products associated with the adverse events.Table 2 demonstrate almost all adverse events associated with the conversion group with the exception blood transfusions which was required in both groups.The article does not provide adequate information to directly associate depuy products with specific adverse events and only provides information that depuy products were in each group among the majority of non-depuy products.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Additional information h6 patient code: hemorrhage.

• 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: 9249448
• MDR Text Key: 177587356
• Report Number: 1818910-2019-112754
• 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,literature
• Type of Report: Initial,Followup,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?: Yes
• 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: 10/29/2019
• Supplement Dates Manufacturer Received: 10/07/2019; 01/03/2020
• Supplement Dates FDA Received: 10/31/2019; 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention