MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN TIB AUG UNIV SZ 3/4 5MM; KNEE TIBIAL TRAY ACCESSORY

Model Number	1523-03-001
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) 2021; (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 : quantity manufactured: 15.Date of manufacture: 9/22/2017.Any anomalies or deviations identified in dhr: na.Expiry date: 8/31/2027.Ifu reference: 090200873 / b.

• Brand Name: ATUN TIB AUG UNIV SZ 3/4 5MM
• Common Device Name: KNEE TIBIAL TRAY ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12915554
• Report Number: 1818910-2021-26866
• Device Sequence Number: 12010580
• Product Code: JWH
• UDI-Device Identifier: 10603295057543
• UDI-Public: 10603295057543
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P830055
• 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): 02/26/2021

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: 1523-03-001
• Device Catalogue Number: 152303001
• Device Lot Number: HG7442
• 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: 09/22/2017
• 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