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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE FEMORAL ADAPTOR BOLT UNK KNEE FEMORAL ADAPTOR BOLT

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DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE FEMORAL ADAPTOR BOLT UNK KNEE FEMORAL ADAPTOR BOLT Back to Search Results
Catalog Number UNK KNEE FEMORAL ADAPTOR BOLT
Device Problems Fracture (1260); Naturally Worn (2988)
Patient Problems Foreign Body Reaction (1868); Not Applicable (3189); No Code Available (3191)
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
This complaint is to capture the multiple cases with the same problem reported in (b)(4). Tc3 bolt and adaptor broke in patient. Outcome was a revison for tc3 femoral component. I don¿t have any implant product lots or part numbers but see descriptions below: femur: 5 tc3. Distal augments: 16 medial and lateral. +2 bolt & 5 degree adaptor. Sz 5 ps rp poly which was removed by osteotome poly from poly bullet. There was metal debris in the joint and the sleeve was well fixed. Xrays and implant will be uploaded. Surgeon dr. (b)(6) removed the femoral component after 30 minutes of work. The 5 degree adaptor was still engaged in the sleeve which we were able to break the taper with slap hammer and five grip using the bolt. There have been multiple cases with the same problem which i have not been a part of. Surgeon was able to re-engage morse taper with an srom hinge implant. Patient status/ outcome / consequences --> yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc. )?--> revison, was other medical intervention (e. G. X-rays, additional procedures, prescriptions, otc, revision) required: --> unknown, if yes, describe --> xrays will be attached , is the patient part of a clinical study --> unknown, (b)(4). Device property of -->none, device in possession of -->none. By checking this box i certify that all information that are known/available has been disclosed. If any new information will be made available, the additional information will be submitted through cst. --> true.
 
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Brand NameUNKNOWN KNEE FEMORAL ADAPTOR BOLT
Type of DeviceUNK KNEE FEMORAL ADAPTOR BOLT
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
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9874441
MDR Text Key189845427
Report Number1818910-2020-09132
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK KNEE FEMORAL ADAPTOR BOLT
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 Received04/16/2020
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: 03/24/2020 Patient Sequence Number: 1
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