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U.S. Department of Health and Human Services

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

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DEPUY IRELAND - 9616671 UNK HIP FEMORAL STEM ACTIS Back to Search Results
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.
 
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Brand NameUNK HIP FEMORAL STEM ACTIS
Type of DeviceFEMORAL 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 Key14023453
MDR Text Key288686128
Report Number1818910-2022-06200
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeAU
Number of Events Reported1
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 Received04/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP FEMORAL STEM ACTIS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/18/2022
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
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