MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 9 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number	1504-10-109
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	08/07/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.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 a left knee revision due to pain.The surgeon reported the patella was well-fixed, had no wear, and was retained.He noted the femoral component was removed with osteotomes, also with no significant bone loss.The surgeon indicated the tibial component was removed with flexible osteotomes and no significant bone loss.The patient was implanted with competitor components and competitor bone cement.There were not surgical complications reported.Doi: (b)(6) 2014; dor: (b)(6) 2015; left knee.
Additional Manufacturer Narrative
This is a duplicate report of orig mfr.(1818910-2015-33510).1818910-2019-123839 is being retracted as it is a report duplication.Original mfr-(1818910-2015-33510) will be kept for investigational purposes.

• Brand Name: ATTUNE PS FEM LT SZ 9 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9490484
• Report Number: 1818910-2019-123839
• Device Sequence Number: 10827678
• Product Code: JWH
• UDI-Device Identifier: 10603295041665
• UDI-Public: 10603295041665
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K111433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2019

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: 08/31/2023
• Device Model Number: 1504-10-109
• Device Catalogue Number: 150410109
• Device Lot Number: 425243
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE MEDIAL DOME PAT 38MM; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 122