MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM RT SZ 3 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Catalog Number	150400203
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	12/21/2015
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
Medical records received 17 june 2019 and were reviewed 15 october 2019 for mdr reportability.On unknown date, the patient underwent total right knee arthroplasty due to unknown diagnoses.There was no history, nor operative notes included in the patient¿s medical information.A sticker page located on page 12/13, indicated the patient had been implanted with attune components and competitor cement in the primary operation.On (b)(6) 2015, the patient underwent a left knee revision due to pain and flexion instability.The surgeon offered no concerns with any of the implanted components.The tibial and the femoral components were revised.The patellar component was not revised.The patient was implanted with a competitor system and there were no complications to the procedure.Doi: unknown.Dor: (b)(6) 2015.(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 at this time.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 FEM RT SZ 3 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9291490
• Report Number: 1818910-2019-114807
• Device Sequence Number: 19298870
• Product Code: JWH
• UDI-Device Identifier: 10603295041184
• UDI-Public: 10603295041184
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2019

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: 05/31/2023
• Device Catalogue Number: 150400203
• Device Lot Number: 3620142
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 12/06/2019
• 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: 46 YR