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 Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	03/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 loosening tibial construct, right knee event is serious and is considered severe event is definitely related to device and is possibly related to procedure.Date of implantation: (b)(6) 2020 date of event (onset): (b)(6) 2021 (right knee) treatment: revision on (b)(6) 2021, of femur, tibial tray, tibial insert, tibial augment, tibial stem, tibial offset adaptor; patella 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: (b)(4).Date of manufacture: 9/22/2017.Any anomalies or deviations identified in dhr: na.Expiry date: 8/31/2027.Ifu reference: 090200873 / b.
Event or Problem Description
Updates received: treatment/impact: hospitalization (initial or prolonged): yes required intervention to prevent permanent impairment or damage: yes.
Additional Manufacturer Narrative
Product complaint #(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: b5.Corrected: d3 manufacturer email.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• 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 RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 11790981
• Report Number: 1818910-2021-09767
• Device Sequence Number: 17105433
• 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,Followup
• Report Date (Section B): 04/16/2021

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 06/08/2021; 04/16/2026
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 06/10/2021; 04/23/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUN REV OFFST STM ADPTR 4MM; ATTUNE CR FB INSRT SZ 5 5MM; ATTUNE CR FEM RT SZ 5 NAR CEM; ATTUNE MEDIAL DOME PAT 38MM; ATUN TIB AUG UNIV SZ 3/4 5MM; ATUNE CRS FB TIB BASE SZ 4 CEM; ATUNE PRESSFIT STR STEM12X60MM; COPAL G+C BONE CEMENT; ATTUN REV OFFST STM ADPTR 4MM; ATTUNE CR FB INSRT SZ 5 5MM; ATTUNE CR FEM RT SZ 5 NAR CEM; ATTUNE MEDIAL DOME PAT 38MM; ATUN TIB AUG UNIV SZ 3/4 5MM; ATUNE CRS FB TIB BASE SZ 4 CEM; ATUNE PRESSFIT STR STEM12X60MM; COPAL G+C BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 106 KG