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

Catalog Number	151620712
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	11/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(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
On (b)(6) 2015, the patient underwent the removal of antibiotic spacer and re-implantation of the permanent total left knee arthroplasty, including patellar, femoral, tibial components and polyethylene insert.The surgeon reported no intraoperative complications.The patient was implanted with the attune knee system and smartset bone cement x 3.On (b)(6) 2017, the patient underwent a right knee revision due to loosening of the tibial component, flexion instability, and pain.The surgeon reported the removal of the tibial component with a combination of double and single-sided reciprocating saws.He noted the femoral component was removed with a double-sided reciprocating saw to disrupt the femoral to cement interface.The surgeon indicated the patella was well-fixed and without significant damage, and not revised.The patient was implanted with a competitor system and there were no complications to the procedure.Doi: (b)(6) 2015.Dor: (b)(6) 2017, (rt knee).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE CR FB INSRT SZ 7 12MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9475755
• Report Number: 1818910-2019-123203
• Device Sequence Number: 2763795
• Product Code: JWH
• UDI-Device Identifier: 10603295045939
• UDI-Public: 10603295045939
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2019

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: 05/31/2017
• Device Catalogue Number: 151620712
• Device Lot Number: 254615
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 119