MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 5 10MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-40-510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Synovitis (2094); Swelling/ Edema (4577)
Date of Event	11/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient received a left primary attune tka to treat end-stage arthritis with varus alignment.The patella was resurfaced and depuy cement x 2 was utilized.The procedure was completed without complications.Patient received a left knee revision to treat pain, swelling, and increased varus deformity secondary to loosening and collapse of the tibial tray.Upon entering the joint, the surgeon identified and debrided synovitis and scar tissue.The tibial tray was grossly loose and debonded at the cement to implant interface and revised.The surgeon notes there were some tibial cavitary defects identified after the tibial tray was explanted.There was no reported product problem with the revised tibial insert.The patella and femoral components were well-fixed and retained.The patient was revised with attune tibial revision components utilizing competitor cement.The procedure was completed without complications.Doi: (b)(6) 2014; dor: (b)(6) 2021; left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.

• Brand Name: ATTUNE PS FB INSRT SZ 5 10MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13657151
• Report Number: 1818910-2022-03949
• Device Sequence Number: 16620955
• Product Code: NJL
• UDI-Device Identifier: 10603295049968
• UDI-Public: 10603295049968
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K111433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• 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): 03/02/2022

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: 12/31/2017
• Device Model Number: 1516-40-510
• Device Catalogue Number: 151640510
• Device Lot Number: 316481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2022
• Supplement Date Received by Manufacturer: 03/26/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 03/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE FB TIB BASE SZ 5 CEM.; ATTUNE MEDIAL DOME PAT 35MM.; ATTUNE PS FEM LT SZ 5 CEM.; SMARTSET GMV 40G US EO.; SMARTSET MV 40G - EO.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female