MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR RP INSRT SZ7 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151630707
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	02/06/2019
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) 2016, the patient underwent total left knee arthroplasty due to arthritis.The patella was resurfaced.The surgeon reported no intraoperative complications.The patient was implanted with depuy knee system and competitor bone cement.On (b)(6) 2019, the patient underwent a left knee revision due to arthrofibrosis, and decreased range of motion.The surgeon indicated extensive amount of scar tissue was present on the undersurface of the quadriceps and also undersurface of the patellar tendon.Scar tissue was excised.The patella was not revised.There were no complaints against the femoral nor tibial components and they were revised.The patient was implanted with depuy components and competitor cement.There were no complications to the procedure.Doi: (b)(6) 2016.Dor: (b)(6) 2019.(lt 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 will be filed as appropriate.

• Brand Name: ATTUNE CR RP INSRT SZ7 7MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9349628
• Report Number: 1818910-2019-117269
• Device Sequence Number: 14338051
• Product Code: NJL
• UDI-Device Identifier: 10603295048008
• UDI-Public: 10603295048008
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2019

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 Catalogue Number: 151630707
• Device Lot Number: 8011818
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 12/17/2019
• 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: 56 YR