MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 5 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number	1504-10-105
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Unspecified Tissue Injury (4559)
Date of Event	05/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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 who received attune primary knee replacement in [year] required component removal and attune revision surgery.Patient had bmi of 51 and chronic valgus knee.Upon x-ray review implants from [year] appeared not to sitting correctly.Tibia had high degree of slope.Femur was notched.Patient had been in pain when walking.Decision was made to revise all components doi: unknown, dor: (b)(6) 2023, affected side: unknown.
Event or Problem Description
Additional information received indicates that the affected side involved in this event was the left knee.
Additional Manufacturer Narrative
Product complaint # (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.Device history lot a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.H10 additional narrative: added: b5 and d6a.

• Brand Name: ATTUNE PS FEM LT SZ 5 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17018840
• Report Number: 1818910-2023-11099
• Device Sequence Number: 12550483
• Product Code: JWH
• UDI-Device Identifier: 10603295041627
• UDI-Public: 10603295041627
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2023

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: 1504-10-105
• Device Catalogue Number: 150410105
• 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: 05/18/2023
• Supplement Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 06/09/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE PS RP INSRT SZ 5 7MM.; ATTUNE RP TIB BASE SZ 5 CEM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 117 KG