MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUNE CRS FB TIB BASE SZ 3 CEM; ATTUNE STEMMABLE TIBIA IMPLANTS : KNEE TIBIAL TRAY

Model Number	1506-40-003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # : (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
Clinical adverse event received for persisting pain.Event is not serious and is considered moderate.Event is probably related to device and is definitely not related to procedure.Date of implantation: (b)(6) 2019.Date of event (onset): (b)(6) 2020.(left knee).Treatment: injected and oral medications (unspecified), physical therapy.
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.Device history lot: product code 150640003.Work order 8762124 was manufactured on 24-march-2018.(b)(4) parts were manufactured per specification and all raw materials met specification.1 scrap part associated with this lot.1 part scrapped for scrap code a888: ctq 10 cone length.This scrap code has no correlation with the complaint failure mode.No reprocessing associated with this lot.No deviations found.

• Brand Name: ATUNE CRS FB TIB BASE SZ 3 CEM
• Common Device Name: ATTUNE STEMMABLE TIBIA IMPLANTS : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11933346
• Report Number: 1818910-2021-11811
• Device Sequence Number: 3831268
• Product Code: JWH
• UDI-Device Identifier: 10603295042778
• UDI-Public: 10603295042778
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K160700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

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 Model Number: 1506-40-003
• Device Catalogue Number: 150640003
• Device Lot Number: 8762124
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 08/18/2021
• 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: ATTUN REV OFFST STM ADPTR 2MM; ATTUN REV OFFST STM ADPTR 6MM; ATTUNE CRS FB INSRT SZ 4 6MM; ATTUNE CRS FEMORAL LT SZ 4 CEM; ATTUNE DIST FEM AUG SZ 4 8MM; ATTUNE DIST FEM AUG SZ 4 8MM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE POS FEM AUG SZ 4 4MM; ATUNE CRS FB TIB BASE SZ 3 CEM; ATUNE PRESSFIT STR STEM14X60MM; ATUNE PRESSFIT STR STEM18X60MM; PALACOS R+G:66017747/91194795; PALACOS R+G:66017775/90445293
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Weight: 88