MAUDE Adverse Event Report: DePuy Ireland - 9616671 ATTUNE; Knee Instruments: Stem Trials

Catalog Number	250440514
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a product demonstration, it was no longer possible to unscrew the instruments.It had become wedged.
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.Additional narrative: h3, h6: investigation summary the product was returned to depuy synthes for evaluation.Visual inspection of the atune rev fem stm stblzr 14 revealed that it was returned disassembled from the atun rev fem 6mm offst gde r.Additionally, it was noted that the device has its internal threads and proximal initial edges stripped.Noticeable sings of repetitive use were identified on the overall device surface.A functional test was performed by attempting to assemble the attune rev fem stm stblzr 14 to the atun rev fem 6mm offst gde r.Assembly could not be completed due to the observed stripped-thread condition.This condition may impair proper assembly and disassembly of the components.The observed condition was identified as an end of life indicator; damage consistent with repeated use and servicing.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A manufacturing record evaluation was performed for the finished device so2032274 number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The overall complaint was confirmed as the observed condition of the attune rev fem stm stblzr 14 would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to end of life, and it has been determined that no corrective and/or preventative action is required.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 date of manufacture: january 17, 2018 any anomalies or deviations identified in dhr: none expiry date: n/a device history review a manufacturing record evaluation was performed for the finished device so2032274 number, and no non-conformances / manufacturing irregularities were identified during manufacturing.

• Brand Name: ATTUNE
• Common Device Name: Knee Instruments: Stem Trials
• Manufacturer (Section D): DePuy Ireland - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50871787
• Report Number: 1818910-2026-16443
• Device Sequence Number: 10716119
• Product Code: LXH
• UDI-Device Identifier: 10603295438144
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 250440514
• Device Lot Number: SO2032274
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/28/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2018
• 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