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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE FEMORAL Back to Search Results
Catalog Number UNK KNEE FEMORAL
Device Problems Loss of or Failure to Bond (1068); Off-Label Use (1494); Noise, Audible (3273)
Patient Problems Fall (1848); Pain (1994); No Code Available (3191)
Event Date 06/25/2019
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

The patient was revised to address pain and loosening of the femur, adaptor bolt and adaptor at the cement to implant interface. Unknown cement was used. It was reported that the patient heard a crunching noise after a fall and has had anterior knee pain since. The surgeon planned on changing the poly and determine the causes of pain. Once in joint, the tc3 adaptor bolt and part of the adapter came out (adapter bolt/adaptor completely broke off from femur and femoral sleeve. ) next, the femur came out since it was no longer attached to the sleeve or distal femur. The surgeon decided that he was going to change the poly and cement the femur back on to use as a spacer till a further date when he could determine a new plan for the case. Doi: (b)(6) 2014; dor: (b)(6) 2019; left knee.

 
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

(b)(4).

 
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Brand NameUNKNOWN KNEE FEMORAL
Type of DeviceKNEE FEMORAL
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
1210 ward avenue
west chester, IN 19380-0988
6107428552
MDR Report Key8793343
MDR Text Key151154630
Report Number1818910-2019-98445
Device Sequence Number1
Product Code KWA
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,Followup
Report Date 06/25/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/16/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK KNEE FEMORAL
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 Received10/30/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/16/2019 Patient Sequence Number: 1
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