MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 8 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-50-807
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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.
Event or Problem Description
On (b)(6) 2017 the patient had a right total knee replacement to address right knee osteoarthritis with varus deformity.There were no complications noted during the procedure.Part/lot page 4 of 25 on (b)(6) 2021, the patient had a right revision to address failed knee arthroplasty.Prior to surgery, the patient was noted to have debilitating pain.It was noted that the patient was negative for infection, but loosening work-up was positive, but no mention of loosening was noted in the surgical notes.During the procedure, the surgeon noted the tibial tray, insert, and femur were revised.There was no specific allegation of deficiency.Doi: (b)(6) 2017 dor: (b)(6) 2021 (right knee).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary patient product photographs have been provided for review.No device associated with this report was received for examination.Provided images are paper copies within patient medical records.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 8 7MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND - 9616671; loughbeg, ringaskiddy co; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 11837058
• Report Number: 1818910-2021-10494
• Device Sequence Number: 14400152
• Product Code: NJL
• UDI-Device Identifier: 10603295052869
• UDI-Public: 10603295052869
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 12/10/2020

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: 03/31/2019
• Device Model Number: 1516-50-807
• Device Catalogue Number: 151650807
• Device Lot Number: 7872036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 01/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2014
• 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 MEDIAL DOME PAT 41MM; ATTUNE PS FEM RT SZ 8 CEM; ATTUNE PS RP INSRT SZ 8 7MM; ATTUNE RP TIB BASE SZ 8 CEM; STRYKER SIMPLEX BONE CEMENT; STRYKER SIMPLEX BONE CEMENT; STRYKER SIMPLEX BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male