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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS RP INSRT SZ 5 12MM; KNEE TIBIAL INSERT
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DEPUY IRELAND - 9616671 ATTUNE CRS RP INSRT SZ 5 12MM; KNEE TIBIAL INSERT Back to Search Results
Model Number 1517-10-512
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Wound Dehiscence (1154); Fall (1848)
Date of Event 03/11/2021
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
It was reported that the patient fell while chasing dog and incision site was split open.Opted to swap out poly and washout.Doi: (b)(6) 2021, dor: (b)(6) 2021, right knee.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
 
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Brand Name
ATTUNE CRS RP INSRT SZ 5 12MM
Common Device Name
KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key11595175
Report Number1818910-2021-06626
Device Sequence Number3423805
Product Code NJL
UDI-Device Identifier10603295055938
UDI-Public10603295055938
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 03/11/2021
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? No
Operator of Device Health Professional
Device Model Number1517-10-512
Device Catalogue Number151710512
Device Lot Number8745620
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/11/2021
Supplement Date Received by Manufacturer05/02/2021
Initial Report FDA Received Date03/31/2021
Supplement Report FDA Received Date05/04/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
ATTUNE CRS RP INSRT SZ 5 12MM; BONE CEMENT (UNK MANUFACTURER & PRODUCT INFO); ATTUNE CRS RP INSRT SZ 5 12MM; BONE CEMENT (UNK MANUFACTURER & PRODUCT INFO)
Outcome Attributed to Adverse Event Required Intervention;
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