MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 4 12MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-50-412
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	07/31/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Patient received primary right knee attune tka to treat osteoarthritis.The surgeon notes that the patient has a long history of right knee instability and pain with multiple right knee surgeries including a fullerton tibial osteotomy for patellar realignment, acl reconstruction, a medial meniscectomy and a lateral meniscectomy.The patella was resurfaced and depuy cement x 1 was utilized.The surgeon notes that the patient had residual tightness in extension, which was repaired with pie crusting of the it band.The tibial tunnel from the previous acl reconstruction was still patent and carefully plugged.After final implantation, the surgeon notes there was mild residual medial laxity which he deemed acceptable for the patient.The procedure was completed without complications.(b)(6) 2019: patient received a right knee revision to treat pain and global instability secondary to tibial tray loosening.Upon entering the joint, the surgeon debrided periarticular synovitis and evacuated joint effusion.The tibial tray was grossly loose and partially debonded at the cement to implant interface.The surgeon notes that there was also loosening at the tibial bone to competitor cement interface with significant tibial bone loss requiring insertion of a cone.The femoral component was will fixed but revised with minimal femoral bone loss.There was no reported product problem with the revised tibial insert.The patella was well-fixed and retained.The patient received a competitor revision construct.The procedure was completed without complications.Doi: (b)(6) 2015 dor: (b)(6) 2019 (tibial tray, tibial insert, and femoral components revised.Patella retained.) right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Review of the returned photographs could not confirm the reported event.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.

• Brand Name: ATTUNE PS RP INSRT SZ 4 12MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11673470
• Report Number: 1818910-2021-08049
• Device Sequence Number: 2999573
• Product Code: NJL
• UDI-Device Identifier: 10603295052333
• UDI-Public: 10603295052333
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: 1516-50-412
• Device Catalogue Number: 151650412
• Device Lot Number: 3596653
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/04/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FEM RT SZ 4 CEM; ATTUNE PS RP INSRT SZ 4 12MM; ATTUNE RP TIB BASE SZ 4 CEM; DEPUY CMW 1 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR