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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE IMPLANT Back to Search Results
Catalog Number UNK KNEE LPS
Device Problems Loss of or Failure to Bond (1068); Osseointegration Problem (3003)
Patient Problems Fall (1848); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Ambulation Difficulties (2544); Inadequate Osseointegration (2646); Insufficient Information (4580)
Event Date 06/02/2017
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 due to aseptic loosening. Doi: unknown. Dor: (b)(6) 2021, unknown knee side.
 
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Brand NameUNKNOWN KNEE IMPLANT
Type of DeviceKNEE IMPLANT
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 dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key13258610
MDR Text Key283832109
Report Number1818910-2022-00854
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K063686
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 01/14/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received01/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK KNEE LPS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/21/2013
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: 01/14/2022 Patient Sequence Number: 1
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