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	Migration (4003)
Health Effect - Clinical Codes	Fall (1848); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/15/2021
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
Patient was revised due to tibia had collapsed on the lateral side and the patient according to the revision surgeon said that the patient must have fallen.Surgeon believed the mcl was compromised.Surgeon removed all components and felt that putting a hinge tka was best for the patient moving forward.Patient had a primary lt tka done 7-1-2019, patient that time had "soft bone" according to the primary surgeon.The surgeon felt that putting in a stem on tibia tray was best for patient and 2 years later the patient needs a revision.Patella was not removed.Doi: (b)(6) 2019 ; dor: (b)(6) 2021 ; left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.All available x-rays were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• 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
• MDR Report Key: 12301416
• Report Number: 1818910-2021-17506
• Device Sequence Number: 12113245
• Product Code: JWH
• UDI-Device Identifier: 10603295042785
• UDI-Public: 10603295042785
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K160700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

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: 8898837
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 09/02/2021
• 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: ATTUNE CEMENTED STEM 14X30MM; ATTUNE CR FB INSRT SZ 6 7MM; ATTUNE CR FEM LT SZ 6 NAR CEM; ATUNE CRS FB TIB BASE SZ 4 CEM; COMPETITOR CEMENT; ATTUNE CEMENTED STEM 14X30MM; ATTUNE CR FB INSRT SZ 6 7MM; ATTUNE CR FEM LT SZ 6 NAR CEM; ATUNE CRS FB TIB BASE SZ 4 CEM; COMPETITOR CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR