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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 Problem Loss of or Failure to Bond (1068)
Patient Problem No Code Available (3191)
Event Date 07/22/2020
Event Type  Injury  
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
The patient was revised to addressed loosening of the femoral component at cement to implant interface.Unknown cement was used.Doi: unknown, dor: (b)(6) 2020, affected side: right knee.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.
 
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Brand Name
UNKNOWN KNEE FEMORAL
Type of Device
KNEE FEMORAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10356284
MDR Text Key201507351
Report Number1818910-2020-17356
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 07/22/2020
Initial Date FDA Received08/03/2020
Supplement Dates Manufacturer Received08/13/2020
Supplement Dates FDA Received08/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
3 X 12.5 CR RP INSERT; UNKNOWN BONE CEMENT
Patient Outcome(s) Required Intervention;
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