MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM TRIAL SZ 5 RT; FEMORAL TRIALS

Catalog Number	254500705
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that during cleaning and sterilization processes it was observed that devices exhibit damage and wear in the condyle area.In addition chips and scratches are also visible in the device photos provided.There was no patient involvement and no surgical delay.
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: 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: according to the information received, ¿hcp is complaining the trials as they show damage/wear in the condyle area.Seen in cssd.No patient involvement, no surgical delay.¿ the product was not returned to depuy synthes; however, photos were provided for review.Review of the photographic evidence revealed scratches on the condyle area.No other defects were observed.The observed scratch condition is consistent with the device coming in contact with the saw blade while trialing, care should be taken to avoid saw blade excursion into the femoral trials or implants.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.A manufacturing record evaluation was performed for the finished device [product code.254500705 / lot.Mvmkcp500] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The overall complaint was confirmed as the observed condition of the attune cr fem trial sz 5 rt would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: 1) quantity manufactured: (b)(4).2) date of manufacture: june 14th 2023.3) any anomalies or deviations identified in dhr: none.4) expiry date: none.5) ifu reference: ifu-0902-60-046.Device history review: a manufacturing record evaluation was performed for the finished device [product code.254500705 / lot.Mvmkcp500] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.Corrected: h4.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, ¿hcp is complaining the trials as they show damage/wear in the condyle area.Seen in cssd.No patient involvement, no surgical delay.¿ the product was not returned to depuy synthes, however photos were provided for review.Review of the photographic evidence revealed scratches on the condyle area.No other defects were observed.The observed scratch condition is consistent with the device coming in contact with the saw blade while trialing, care should be taken to avoid saw blade excursion into the femoral trials or implants.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.A manufacturing record evaluation was performed for the finished device [product code.254500705 / lot.Mvmkcp500] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The overall complaint was confirmed as the observed condition of the attune cr fem trial sz 5 rt would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: 1) quantity manufactured: (b)(4).2) date of manufacture: june 14th 2023.3) any anomalies or deviations identified in dhr: none.4) expiry date: none.5) ifu reference: ifu-0902-60-046.Device history review: a manufacturing record evaluation was performed for the finished device [product code.254500705 / lot.Mvmkcp500] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.
Additional Manufacturer Narrative
Product complaint # (b)(4) investigation summary hcp is complaining the trials as they show damage/wear in the condyle area.Seen in cssd.No patient involvement, no surgical delay.The product was returned to depuy synthes for evaluation.Visual inspection of the attune cr fem trial sz 5 rt revealed scratches on both condyles.Additionally, the device exhibits an overall worn appearance consistent with normal and constant usage.The observed scratch condition is consistent with the device coming in contact with the saw blade while trialing, care should be taken to avoid saw blade excursion into the femoral trials or implants.A dimensional inspection and functional testing were not performed as it is not applicable to the complaint condition.A manufacturing record evaluation was performed for the finished device [product code.254500705 / lot.Mvmkcp500] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The overall complaint was confirmed as the observed condition of the attune cr fem trial sz 5 rt would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot 1) quantity manufactured: 329 2) date of manufacture: june 14th 2023 3) any anomalies or deviations identified in dhr: none 4) expiry date: none 5) ifu reference: ifu-0902-60-046.Device history review a manufacturing record evaluation was performed for the finished device [product code.254500705 / lot.Mvmkcp500] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.Corrected: h3.

• Brand Name: ATTUNE CR FEM TRIAL SZ 5 RT
• Common Device Name: FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24456892
• Report Number: 1818910-2026-03772
• Device Sequence Number: 15954413
• Product Code: HWT
• UDI-Device Identifier: 10603295133773
• UDI-Public: (01)10603295133773(10)MVMKCP500
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• 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,Followup,Followup,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: 254500705
• Device Lot Number: MVMKCP500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 03/09/2026; 04/07/2026; 04/14/2026; 04/16/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/20/2026; 04/09/2026; 04/15/2026; 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown