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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.
 
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Brand NameATTUNE MEDIAL DOME PAT 35MM
Type of DeviceATTUNE IMPLANT : KNEE PATELLA
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI
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 Key11694859
MDR Text Key246317812
Report Number1818910-2021-08317
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P830055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2019
Device Model Number1518-20-035
Device Catalogue Number151820035
Device Lot Number7936290
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/04/2014
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: 04/20/2021 Patient Sequence Number: 1
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
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