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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP BAL AP BLK SZ 6 KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

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DEPUY ORTHOPAEDICS INC US SIGMA HP BAL AP BLK SZ 6 KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES Back to Search Results
Model Number 9505-02-132
Device Problem Naturally Worn (2988)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/06/2021
Event Type  malfunction  
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
It was reported that the following items are starting to look worn, tired and in need of replacement. No delays to surgery.
 
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Brand NameSIGMA HP BAL AP BLK SZ 6
Type of DeviceKNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
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 Key12664415
MDR Text Key277358450
Report Number1818910-2021-23005
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9505-02-132
Device Catalogue Number950502132
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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