MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR RP INSRT SZ 9 5MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151630905
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	01/04/2019
Type of Reportable Event	Serious Injury
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 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 = > 8638376.Device history review = > a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
(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) 2018, the patient underwent total left knee arthroplasty due to osteoarthritis.The patella was resurfaced.The surgeon reported no intraoperative complications.The patient was implanted with the attune knee system and smartset bone cement x 3.On (b)(6) 2019, the patient underwent a left knee revision due to ligamentous instability, effusions, limited motion, and tibial loosening.The surgeon indicated the tibial component had completely de-bonded from the tibia cement leaving 100% of the cement intact with the bone interface.Loosening at the tray/cement interface.He noted the femoral component was removed with reciprocating saw and osteotome.The surgeon reported the patella was revised to reduce the thickness for improved flexion.The patient was implanted with attune knee system and unknown bone cement.There were no complications to the procedure.Doi: (b)(6) 2018; dor: (b)(6) 2019 (lt knee).

• Brand Name: ATTUNE CR RP INSRT SZ 9 5MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9362500
• Report Number: 1818910-2019-117551
• Device Sequence Number: 2606328
• Product Code: NJL
• UDI-Device Identifier: 10603295048220
• UDI-Public: 10603295048220
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2019

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: 10/31/2022
• Device Catalogue Number: 151630905
• Device Lot Number: 8638376
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 12/19/2019
• 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: 72 YR