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

Catalog Number	254500705
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
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 there was discoloration/(metal) abrasion of the trials.The issue was seen in cssd.There was no patient involvement and no surgical delay.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : according to the information received, "hcp is complaining a discoloration/(metal) abrasion of the trials." the product was not returned to medtech orthopaedics, however photos were provided for review.(b)(4).The photo investigation revealed that attune cr fem trial sz 5 rt had delaminated and foreign substances are there.This type of damage is consistent with other tools and hard edges coming in contact with the device, properly handling and attention to the approved use of the device diminishes the risk of failure.Since the device was not returned, a dimensional inspection cannot be performed.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, potential cause attributed to unintended use error caused or contributed to even and 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 complaint condition.As part of medtech orthopaedics 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 : a manufacturing record evaluation (nc search) was performed for the finished device product code: 254500705,lot: mvmgml620 and no non-conformances / manufacturing irregularities were identified.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: according to the information received, "hcp is complaining a discoloration/(metal) abrasion of the trials." the product was not returned to medtech orthopaedics; however, photos were provided for review.See attachment (b)(4).The photo investigation revealed that attune cr fem trial sz 5 rt had delaminated and foreign substances are there.This type of damage is consistent with other tools and hard edges coming in contact with the device, properly handling and attention to the approved use of the device diminishes the risk of failure.Since the device was not returned, a dimensional inspection cannot be performed.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, potential cause attributed to unintended use error caused or contributed to even and 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 complaint condition.As part of medtech orthopaedics 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 = > a manufacturing record evaluation (nc search) was performed for the finished device product code: 254500705, lot: mvmgml620 and no non-conformances / manufacturing irregularities were identified.

• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21654824
• Report Number: 1818910-2025-04263
• Device Sequence Number: 15337421
• Product Code: HWT
• UDI-Device Identifier: 10603295133773
• UDI-Public: (01)10603295133773(10)MVMGML620
• 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

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: MVMGML620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 05/19/2025; 05/23/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 05/20/2025; 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2019
• 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