MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUNE CRS FB TIB BASE SZ 4 CEM; ATTUNE STEMMABLE TIBIA IMPLANTS : KNEE TIBIAL TRAY

Model Number	1506-40-004
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/25/2021
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 tibial dislocation.Event is serious and is considered severe.Event is probably related to both device and procedure.Date of implantation: (b)(6) 2020, date of event (onset): (b)(6) 20201, (right knee).Treatment: knee revision (b)(6) 2021.The clinical database now reports that there has been a knee revision--right knee was revised for loosening tibial component, right knee--that occurred on (b)(6) 2021.Tibial tray, tibial insert, tibial stem, offset adaptor, and tibial augment were reportedly revised--femur and patella components were retained.
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/ dhr review: 1) quantity manufactured: 12.2) date of manufacture: 26-jun-2019.3) any anomalies or deviations identified in dhr: lot placed on process hold for qa to review clocking lines, lines were present and deemed acceptable.No correlation with the complaint description.4) expiry date: 31-may-2029.5) ifu reference: (b)(4).

• Brand Name: ATUNE CRS FB TIB BASE SZ 4 CEM
• Common Device Name: ATTUNE STEMMABLE TIBIA IMPLANTS : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND - 9616671; loughbeg, ringaskiddy co; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12915586
• Report Number: 1818910-2021-26867
• Device Sequence Number: 12079987
• Product Code: JWH
• UDI-Device Identifier: 10603295042785
• UDI-Public: 10603295042785
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1506-40-004
• Device Catalogue Number: 150640004
• Device Lot Number: 9189528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2021
• Supplement Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 106 KG