MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 2 CEM; KNEE TIBIAL TRAY

Model Number	1506-80-002
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	05/22/2020
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
The primary surgery was performed on an unknown date via tka for the patient¿s left knee joint.When the primary surgery, the implant was set as malalignment.The surgeon decided to perform the revision surgery because the patient had a pain due to the implant¿s malalignment.It was reported that the revision surgery was performed on (b)(6) 2020 by replacing the tibial tray and the tibial insert.During the revision surgery, the surgeon judged that there was no loosening at the femoral component.The revision surgery was completed.The surgeon commented that there was no causal relation between this even to the products.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.

• Brand Name: ATTUNE RP TIB BASE SZ 2 CEM
• Common Device Name: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10105543
• Report Number: 1818910-2020-12919
• Device Sequence Number: 908325
• Product Code: JWH
• UDI-Device Identifier: 10603295492146
• UDI-Public: 10603295492146
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1506-80-002
• Device Catalogue Number: 150680002
• Device Lot Number: 9037609
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 06/01/2020
• Supplement Report FDA Received Date: 06/25/2020
• 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 CR FEM LT SZ 4 CEM; ATTUNE CR RP INSRT SZ 4 5MM; ATTUNE RP TIB BASE SZ 2 CEM; ATTUNE CR FEM LT SZ 4 CEM; ATTUNE CR RP INSRT SZ 4 5MM; ATTUNE RP TIB BASE SZ 2 CEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR