MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ATUNE CR LT MS INS SZ 6 5; KNEE IMPLANT - TIBIAL INSERT

Catalog Number	151820605
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
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 the information is unknown, not available or does not apply, the section/field of the form is left blank.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
It was reported that during a total knee arthroplasty (tka) with a cruciate-retaining femoral multi-size polyethylene, the surgeon impacted the polyethylene insert and felt the locking mechanism did not engage correctly.The surgeon removed and reinserted the insert several times and opened a second and then a third polyethylene with the same issue.After a fourth polyethylene was opened and still did not satisfy the surgeon, a stemmed tibial component was opened in case tray removal was required and to evaluate whether the tibial tray might be causing the locking failure; the team attempted to engage the polyethylene and tray on the back table.The surgeon was not convinced that changing trays would resolve the problem and ultimately implanted a 6x7 left multi-size polyethylene, although the surgeon remained not fully satisfied at the conclusion of the case.No further information is available.Doe: (b)(6) 2025.Affected side: left knee.
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: d10 concomitant.Corrected: d4 primary udi.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.According to the information received, it was reported that tka cr femur ms poly- surgeon impacted poly and felt like the locking mechanism did not lock in correctly tried several times took poly in and out opened a new poly and repeated felt like locking mechanism did not work again opened a 3rd poly.Same issues were occurring surgeon was doing all the correct steps on the technique so we opened a 4th poly still was not satisfied so we opened a stemmed tibia, we opened the stemmed component in case we had to remove the tibial tray , we also opened to see if it was potentially the tray causing the locking mechanism to not work correctly and tried to engage the poly and tray on the back table surgeon was not convinced changing trays would help and we put in a 6x7 left ms poly surgeon still did not feel satisfied at the end of the case.Doe: (b)(6) 2025 affected side: left knee.Product description: -atune cr lt ms ins sz 6 5 product code: -151820605 lot no: -m71r97 1.Quantity of manufactured - 48 2.Date of manufacturing -16-aug-2024 3.Expiry date - 31-jul-2032 4.Any anomalies or deviations identified in dhr: none 5.Ifu reference: (b)(4) a manufacturing record evaluation was performed for the finished device product description: atune cr lt ms ins sz 6 5 product code: 151820605 lot number: m71r97 and zero non-conformances were identified, however not related to the reported failure mode of the complaint.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: -atune cr lt ms ins sz 6 5 product code: -151820605 lot no: -m71r97 1.Quantity of manufactured - 48 2.Date of manufacturing -16-aug-2024 3.Expiry date - 31-jul-2032 4.Any anomalies or deviations identified in dhr: none 5.Ifu reference: (b)(4) device history review: a manufacturing record evaluation was performed for the finished device product description: atune cr lt ms ins sz 6 5 product code: 151820605 lot number: m71r97 and zero non-conformances were identified, however not related to the reported failure mode of the complaint.

• Brand Name: ATUNE CR LT MS INS SZ 6 5
• Common Device Name: KNEE IMPLANT - TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23830301
• Report Number: 1818910-2025-22089
• Device Sequence Number: 5068202
• Product Code: JWH
• UDI-Device Identifier: 10603295541721
• UDI-Public: (01)10603295541721(17)320731(10)M71R97
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K211609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• 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,Followup,Followup
• Report Date (Section B): 12/17/2025

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: 151820605
• Device Lot Number: M71R97
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 01/23/2026; 02/01/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 01/30/2026; 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2024
• 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: ATUNE CR LT MS INS SZ 6 5.; ATUNE CR LT MS INS SZ 6 6.; ATUNE CR LT MS INS SZ 6 6.; ATUNE CRS FB TIB BASE SZ 6 CEM.
• Patient Sex: Male