MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 5 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-20-506
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	11/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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
Patient was revised for pain and instability.Explanted the femur and tibial insert and tibial tray.Implant an attune crs femur with an augment and pressfit stem, rp revision tray with cemented stem and 14mm crs rp insert.This was the patient's left knee.There was no delay in surgery or injury to the patient.Original dos on (b)(6) 2018 at the same hospital.Doi: (b)(6) 2018.Dor: (b)(6) 2022.Left knee.

• Brand Name: ATTUNE CR FB INSRT SZ 5 6MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15892965
• Report Number: 1818910-2022-24045
• Device Sequence Number: 20148333
• Product Code: JWH
• UDI-Device Identifier: 10603295045656
• UDI-Public: 10603295045656
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/01/2022

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: 1516-20-506
• Device Catalogue Number: 151620506
• 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: 11/08/2022
• Initial Report FDA Received Date: 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 93 KG