MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ10 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-51-006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	05/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Initial reporter occupation: non-healthcare professional "attorney".(b)(4).
Event or Problem Description
On (b)(6) 2018, revised to address loosening of the tibial and femoral components, and pain.The surgeon reported a lot of adhesion tissue around the patella and patellar tendon.He indicated the knee was very stiffness.There was no adherence at the femoral - cement to implant interface.The surgeon indicated the tibial component was completely loose at the component to cement interface.He noted the patella was found to be placed lateral and with some wear, and revised.The patient was implanted with a competitor system and there were no complications to the procedure.Doi: (b)(6) 2015 (tibial tray, cement, patella and femoral component); doi: (b)(6) 2016 (tibial insert); dor: (b)(6) 2018 (left knee).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.Device history lot: 7872108.Device history batch: null.Device history review: 16 parts were manufactured per specification and all raw materials met specification.There were no deviations associated with this lot.There was one nc associated with this lot: nr-0099319.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 PS RP INSRT SZ10 6MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• MDR Report Key: 9497792
• Report Number: 1818910-2019-124180
• Device Sequence Number: 19574952
• Product Code: JWH
• UDI-Device Identifier: 10603295053132
• UDI-Public: 10603295053132
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

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: 02/28/2019
• Device Model Number: 1516-51-006
• Device Catalogue Number: 151651006
• Device Lot Number: 7872108
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 02/01/2020
• 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: 53 YR