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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD
Device Problems Corroded (1131); Degraded (1153); Naturally Worn (2988)
Patient Problems Foreign Body Reaction (1868); Necrosis (1971); Tissue Damage (2104); Injury (2348); No Code Available (3191)
Event Date 05/30/2018
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, ""risk factors associated with early complications of revision surgery for head-neck taper corrosion in metal-on-polyethylene total hip arthroplasty"" written by young-min kwon, md, phd, daniel rossi, md, john macauliffe, meng, yun peng, phd, paul arauz, phd published by the journal of arthroplasty accepted by publisher 30 may 2018. The article's purpose was to "" report the early complication rates and the outcomes of revision surgery, and identify potential risk factors associated with complications of revision surgery for altr associated with head neck taper corrosion, in patients with mop tha. "" the data was compiled from 40 patients with various depuy and non depuy products. The article reports on generalized adverse events without patient or identifiers and then lists case identifiers in table 1 with a quantity of 3 cases identified with depuy products (case 4, case 5 and case 6) that are captured individually in linked complaints. Depuy products: summit or trilock stem, cocr femoral head, poly liner, pinnacle cup" this complaint captures case no 5 with a pinnacle cup, poly liner, cocr head and trilock stem that was revised for unknown reason and intraoperative findings were black metal debris at the femoral component trunnion neck taper and the on the bore of the femoral head "grossly indicating corrosion of the head-neck taper junction. Debridement for necrotic periarticular soft tissue, muscle and bone secondary to altr from head-neck taper corrosion. Stem left in intact.
 
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 will be filed as appropriate.
 
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Brand NameUNKNOWN HIP FEMORAL HEAD
Type of DeviceHIP FEMORAL HEAD
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key9452860
MDR Text Key185100969
Report Number1818910-2019-122482
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP FEMORAL HEAD
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/13/2020
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: 12/11/2019 Patient Sequence Number: 1
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