MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 7 12MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-40-712
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Primary operative notes (b)(6) 2016 indicate the patient received a left total knee replacement due to end stage osteoarthritis.The patella was resurfaced, and depuy cement was utilized x2.The surgery was completed without indication of complication by the surgeon.On (b)(6) 2021, the patient underwent a left knee revision to address pain and tibial tray loosening at an unknown interface.The tibial insert, tibial tray, and femoral component were revised.The patella component was retained.The patient was revised with competitor products.There were no indicated intra-operative complications.
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.Investigation summary: no device associated with this report was received for examination.All available photographs were reviewed, pitting was found on the attune ps fb insrt from both sides, which is indicative of debris in the space joint.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.

• Brand Name: ATTUNE PS FB INSRT SZ 7 12MM
• 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: 12949820
• Report Number: 1818910-2021-27296
• Device Sequence Number: 4704178
• Product Code: NJL
• UDI-Device Identifier: 10603295050254
• UDI-Public: 10603295050254
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K111433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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
• Report Date (Section B): 09/30/2021

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 Model Number: 1516-40-712
• Device Catalogue Number: 151640712
• Device Lot Number: 647630
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2015
• 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 7 CEM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PS FB INSRT SZ 7 12MM; ATTUNE PS FEM LT SZ 7 CEM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male