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

Catalog Number UNK HIP FEMORAL HEAD

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

Patient Problem Wound Dehiscence (1154)

Event Date 07/19/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

Article entitled "patient-specific implants for pelvic tumor resections" written kevin doring, kevin staats, stephan puchner, and reinhard windhager published by journal of personalized medicine on (b)(6) 2021, was reviewed.This study was conducted as a retrospective analysis of the vienna bone and soft tissue tumor registry at the orthopedic department of the medical university of vienna analyzing patients who were treated for malign pelvic bone tumors using custom made prostheses between 1990 and 2000.20 patients with histologically verified periacetabular malignancy and a median follow up time of 5 years were included.Depuy synthes implants were noted to have been used in 2 patients.One patient was note have a 3d ¿ printed custom-made prosthesis with a competitor cup.An actis stem and femoral head were placed in (b)(6) 2020.One year after surgery, the (b)(6) year-old patient can walk for an hour with crutches, while smaller distances can be completed without walking aid.This isn¿t be captured as an adverse event as the patient suffered from chondrosarcoma and received a type ii and iii wide resection prior to the placement of the devices.The second patient suffered from an osteosarcoma and received a type i and ii wide resection and implantation of a 3d-printed customer made competitor prosthesis and competitor cup.An actis femoral stem and head were placed as well.Wound dehiscence lead to surgical debridement four months after placement.Two years after surgery, the (b)(6) year-old patient was pain free and has moderate limb walk with no walking aid required.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this report was not received for examination.The x-ray images within the journal article have been reviewed.No evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot : a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14023472
• MDR Text Key: 288687133
• Report Number: 1818910-2022-06201
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2022

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 HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2022
• Initial Date FDA Received: 04/06/2022
• Supplement Dates Manufacturer Received: 06/10/2022
• Supplement Dates FDA Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention