MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUNE CRS FB TIB BASE SZ 5 CEM; ATTUNE STEMMABLE TIBIA IMPLANTS : KNEE TIBIAL TRAY

Model Number	1506-40-005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	12/12/2018
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 mid to distal anterior thigh pain on (b)(6) 2017, the patient had a revised total right knee to address instability.Depuy components along with competitor cement x2, were implanted during this procedure.(b)(6) 2019 medical records note that the patient presents with pain in right knee and hip, with buckling and swelling of the right knee.Left knee pain due to oa changes (natural knee).Patient is doing physical therapy date of implantation: (b)(6) 2017.Date of event (onset): (b)(6) 2018.(right knee) treatment: 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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ATUNE CRS FB TIB BASE SZ 5 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: 11992849
• Report Number: 1818910-2021-12555
• Device Sequence Number: 10993895
• Product Code: JWH
• UDI-Device Identifier: 10603295042792
• UDI-Public: 10603295042792
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K160700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2021

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: 1506-40-005
• Device Catalogue Number: 150640005
• Device Lot Number: 8567038
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 07/06/2021
• 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 4MM; ATTUNE CRS FB INSRT SZ 5 12MM; ATTUNE CRS FEMORAL RT SZ 5 CEM; ATUN PRESSFIT STR STEM14X110MM; ATUN PRESSFIT STR STEM16X110MM; ATUNE CRS FB TIB BASE SZ 5 CEM; COMPETITOR BONE CEMENT (ZIMMER PALACOS R); COMPETITOR BONE CEMENT (ZIMMER PALACOS R); ATTUN REV OFFST STM ADPTR 4MM; ATTUNE CRS FB INSRT SZ 5 12MM; ATTUNE CRS FEMORAL RT SZ 5 CEM; ATUN PRESSFIT STR STEM14X110MM; ATUN PRESSFIT STR STEM16X110MM; ATUNE CRS FB TIB BASE SZ 5 CEM; COMPETITOR BONE CEMENT (ZIMMER PALACOS R); COMPETITOR BONE CEMENT (ZIMMER PALACOS R)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Weight: 103