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 Code	Joint Laxity (4526)
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 knee instability.Event is not serious and is considered moderate.Event is possibly related to device and is definitely not related to procedure.Date of implantation: (b)(6) 2017, date of event (onset): (b)(6) 2018, (right knee).Treatment: physical therapy & knee brace.
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 at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.

• 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: 11885685
• Report Number: 1818910-2021-11207
• Device Sequence Number: 19760366
• 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: 05/12/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 05/26/2021
• 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; ZIMMER PALACOS R BONE CEMENT; ZIMMER PALACOS R BONE CEMENT; 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; ZIMMER PALACOS R BONE CEMENT; ZIMMER PALACOS R BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Weight: 103