MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK HIP FEMORAL STEM ACTIS

Catalog Number UNK HIP FEMORAL STEM ACTIS

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

(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 july 19, 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.

• Brand Name: UNK HIP FEMORAL STEM ACTIS
• Type of Device: FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• 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: 14023453
• MDR Text Key: 288686128
• Report Number: 1818910-2022-06200
• Device Sequence Number: 1
• Product Code: MEH
• 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
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK HIP FEMORAL STEM ACTIS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2022
• 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 Treatment Data

Date Received: 04/06/2022 Patient Sequence Number: 1

Treatment

UNKNOWN HIP FEMORAL HEAD