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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SP*2 FEM LOCATG DEV OUTRIGGER; KNEE INSTRUMENT : ALIGNMENT DEVICES

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DEPUY ORTHOPAEDICS INC US SP*2 FEM LOCATG DEV OUTRIGGER; KNEE INSTRUMENT : ALIGNMENT DEVICES Back to Search Results
Model Number 96-6112
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/28/2020
Event Type  malfunction  
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
Match issue.It was reported that as the event (b)(4) happened, considering safety, the distributor checked the same lot products, noted the impact product also with the same issue: 966112 could not pass the way through the slot/hole of 966115.There were no adverse consequences to the patient.No additional information could be provided.
 
Manufacturer Narrative
Product complaint # (b)(4).This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.
 
Manufacturer Narrative
Product complaint #
=
>(b)(4) this product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.
 
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Type of Device
KNEE INSTRUMENT : ALIGNMENT DEVICES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10052934
MDR Text Key191268789
Report Number1818910-2020-12053
Device Sequence Number1
Product Code HAW
UDI-Device Identifier10603295246855
UDI-Public10603295246855
Combination Product (y/n)N
PMA/PMN Number
K043223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 04/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number96-6112
Device Catalogue Number966112
Device Lot NumberGM5197201
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/28/2020
Initial Date FDA Received05/13/2020
Supplement Dates Manufacturer Received07/01/2020
06/24/2020
Supplement Dates FDA Received07/02/2020
07/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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