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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 35MM; ATTUNE IMPLANT : KNEE PATELLA
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DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 35MM; ATTUNE IMPLANT : KNEE PATELLA Back to Search Results
Model Number 1518-20-035
Device Problem Off-Label Use (1494)
Patient Problems Wound Dehiscence (1154); Pain (1994); Joint Laxity (4526); Unspecified Tissue Injury (4559)
Event Date 12/04/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, follow-up medwatch will be filed as appropriate.
 
Event Description
(b)(6) 2019: patient received a right knee competitor insert revision and vmo advancement to treat patellar instability secondary to disruption of the arthrotomy.Upon entering joint, the surgeon discovered the previous arthrotomy was disrupted resulting in patellar instability and easy dislocation of the patella resurfaces with an attune button.The competitor insert was revised with a larger size, and a vmo advancement over the patella was performed.The arthrotomy repaired and the patella was retained.The procedure was completed without complications.There is no indication that the patient experienced a patellar dislocation prior to the revision and arthrotomy repair.Doi: (b)(6) 2015.Dor: (b)(6) 2019 (tibial tray, tibial insert< and femoral components revised.Patella retained.) dor: (b)(6) 2019 (competitor insert revised.Attune patella retained).Right knee.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was not received for examination.Depuy synthes considers the investigation closed.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 MEDIAL DOME PAT 35MM
Type of Device
ATTUNE IMPLANT : KNEE PATELLA
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key11694859
MDR Text Key246317812
Report Number1818910-2021-08317
Device Sequence Number1
Product Code OIY
UDI-Device Identifier10603295056683
UDI-Public10603295056683
Combination Product (y/n)N
PMA/PMN Number
P830055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 04/04/2021
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? Yes
Device Operator Health Professional
Device Expiration Date06/30/2019
Device Model Number1518-20-035
Device Catalogue Number151820035
Device Lot Number7936290
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/04/2021
Initial Date FDA Received04/20/2021
Supplement Dates Manufacturer Received06/02/2021
Supplement Dates FDA Received06/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ATTUNE MEDIAL DOME PAT 35MM; PALACOS BONE CEMENT; STRYKER AUG DST TRI RT SZ4 5MM; STRYKER AUG DST TRI RT SZ4 5MM; STRYKER AUG POST TRI SZ4 5MM; STRYKER AUG POST TRI SZ4 5MM; STRYKER FEM STEM TRI 12MM; STRYKER FEM TRI SZ4; STRYKER TIB AUG SZ3 5MM; STRYKER TIB AUG SZ3 5MM; STRYKER TIB BSPLT UNIV CEMSZ3; STRYKER TIB INS TRI SZ3 13MM; STRYKER TIB STEM EXT CEM 15X50MM; STRYKER TIBIAL STABILIZER 9MM SIZ; TRIATHLON TIBIAL CONE AUGMENT; ATTUNE MEDIAL DOME PAT 35MM; PALACOS BONE CEMENT; STRYKER AUG DST TRI RT SZ4 5MM; STRYKER AUG DST TRI RT SZ4 5MM; STRYKER AUG POST TRI SZ4 5MM; STRYKER AUG POST TRI SZ4 5MM; STRYKER FEM STEM TRI 12MM; STRYKER FEM TRI SZ4; STRYKER TIB AUG SZ3 5MM; STRYKER TIB AUG SZ3 5MM; STRYKER TIB BSPLT UNIV CEMSZ3; STRYKER TIB INS TRI SZ3 13MM; STRYKER TIB STEM EXT CEM 15X50MM; STRYKER TIBIAL STABILIZER 9MM SIZ; TRIATHLON TIBIAL CONE AUGMENT
Patient Outcome(s) Required Intervention;
Patient Age54 YR
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