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

Catalog Number	151640605
Medical Device Problem Codes	Difficult to Insert (1316); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that during a knee surgery, the insert did not fit in the tibial base because one of the fins was bent.Surgery was delayed by five minutes due to the event.Another implant was used, and the procedure was completed successfully with no patient consequence.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Product description:- attune ps fb insrt sz 6 5mm.Product code:- 151640605.Lot no:- m8800p.Quantity of manufactured:- (b)(4).Date of manufacturing:- 21-mar-2025.Expiry date:- 28-feb-2030.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: product description:- attune ps fb insrt sz 6 5mm.Product code:- 151640605.Lot no:- m8800p.Quantity of manufactured:- (b)(4).Date of manufacturing:- 21-mar-2025.Expiry date:- 28-feb-2030.A manufacturing record evaluation was performed for the finished device, and no non-conformances / manufacturing irregularities were identified.H11 additional narrative: added: d10.

• Brand Name: ATTUNE PS FB INSRT SZ 6 5MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23024723
• Report Number: 1818910-2025-15669
• Device Sequence Number: 9701637
• Product Code: JWH
• UDI-Device Identifier: 10603295050063
• UDI-Public: (01)10603295050063(17)300228(10)M8800P
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• PMA/510(K) Number: K111433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 151640605
• Device Lot Number: M8800P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2025
• 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 FB INSRT SZ 6 5MM
• Patient Sex: Female