MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 4 NAR CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number	1504-10-124
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Edema (1820); Pain (1994)
Date of Event	07/22/2016
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.
Event or Problem Description
Revision of the left knee secondary to pain, swelling, stiffness and suspected malrotation.Intraoperatively, the surgeon discovered tibial loosening at the cement to implant interface.Due to the malrotation, a completed revision of the tibial and femoral components to a rotation platform design.Doi: (b)(6) 2013; dor: (b)(6) 2016; (left 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.H10 additional narrative:  corrected: h6 (device).

• Brand Name: ATTUNE PS FEM LT SZ 4 NAR CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9547500
• Report Number: 1818910-2020-00421
• Device Sequence Number: 14014637
• Product Code: JWH
• UDI-Device Identifier: 10603295041696
• UDI-Public: 10603295041696
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2019

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: 08/31/2022
• Device Model Number: 1504-10-124
• Device Catalogue Number: 150410124
• Device Lot Number: 275580
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 07/21/2020
• 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 35MM; COMPETITOR'S BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR