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

Catalog Number	151620505
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
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.H11 additional narrative: e1 initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that during the surgery, the gasket cannot be inserted.Could not lock the insert.Another device was used to complete the surgery.The surgery delayed for five minutes.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary could not lock the insert.It was reported that during the surgery, the gasket cannot be inserted (as the photo shows).Another device was used to complete the surgery.The surgery delayed for 5 minutes.There were no adverse consequences to the patient.No additional information could be provided.The product was not returned to j&j medtech orthopaedics, however a photo was provided for review.The photo investigation revealed that the locking mechanism tab of the attune cr fb insrt sz 5 5mm appears to be deformed.Additionally, displays marks on the surface which are typical for an insert that has attempted to be placed on the tibial base.Functionality issues of the device cannot be assessed through a photo investigation.However, due to the visual damage observed, the difficulty/inability to assemble mating devices can be confirmed.A manufacturing record evaluation was performed for the finished device product code: 151620505 lot number: m6646w, and no non-conformances or manufacturing irregularities were identified.As per attune¿ knee system intuition ¿ surgical technique rev.K, on pages 79-80, the next steps need to be followed for a proper implantation of the attune cr fb insrt with the fixed bearing tibial base: "angle the tibial insert posteriorly and slide the posterior tabs into the posterior undercuts of the tibial base.The fixed bearing tibial insert is impacted into place on the tibial base, using the fixed bearing insert impactor.Position the impactor at approximately 60 degrees on the insert so that the notch rests on the anterior edge of the center of the insert.Use a mallet to strike the fixed bearing insert impactor".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.The overall complaint was confirmed as the observed condition of the attune cr fb insrt sz 5 5mm 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 j&j 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 was performed for the finished device product code: 151620505 lot number: m6646w, and no non-conformances or manufacturing irregularities were identified.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: could not lock the insert.It was reported that during the surgery, the gasket cannot be inserted (as the photo shows).Another device was used to complete the surgery.The surgery delayed for 5 minutes.There were no adverse consequences to the patient.No additional information could be provided.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device revealed that the locking mechanism tab of the attune cr fb insrt sz 5 5mm was deformed.Additionally, displays marks on the surface which are typical for an insert that has attempted to be placed on the tibial base.The posterior grooves were found slightly delaminated.The mating tibial tray component was not returned; therefore, a functional test was not able to be performed.However, due to the visual damage observed, the difficulty/inability to assemble mating devices can be confirmed.A manufacturing record evaluation was performed for the finished device product code: 151620505 lot number: m6646w, and no non-conformances or manufacturing irregularities were identified.As per attune¿ knee system intuition ¿ surgical technique rev.K, on pages 79-80, the next steps need to be followed for a proper implantation of the attune cr fb insrt with the fixed bearing tibial base: "angle the tibial insert posteriorly and slide the posterior tabs into the posterior undercuts of the tibial base.The fixed bearing tibial insert is impacted into place on the tibial base, using the fixed bearing insert impactor.Position the impactor at approximately 60 degrees on the insert so that the notch rests on the anterior edge of the center of the insert.Use a mallet to strike the fixed bearing insert impactor".A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the attune cr fb insrt sz 5 5mm 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 j&j 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 was performed for the finished device product code: 151620505 lot number: m6646w, and no non-conformances or manufacturing irregularities were identified.H11 additional narrative: corrected: h3.
Additional Manufacturer Narrative
Product complaint # (b)(4) investigation summary could not lock the insert.It was reported that during the surgery, the gasket cannot be inserted (as the photo shows).Another device was used to complete the surgery.The surgery delayed for 5 minutes.There were no adverse consequences to the patient.No additional information could be provided.The product was not returned to j&j medtech orthopaedics; however, a photo was provided for review.The photo investigation revealed that the locking mechanism tab of the attune cr fb insrt sz 5 5mm appears to be deformed.Additionally, displays marks on the surface which are typical for an insert that has attempted to be placed on the tibial base.Functionality issues of the device cannot be assessed through a photo investigation.However, due to the visual damage observed, the difficulty/inability to assemble mating devices can be confirmed.A manufacturing record evaluation was performed for the finished device product code: 151620505 lot number: m6646w, and no non-conformances or manufacturing irregularities were identified.As per attune¿ knee system intuition ¿ surgical technique rev.K, on pages 79-80, the next steps need to be followed for a proper implantation of the attune cr fb insrt with the fixed bearing tibial base: "angle the tibial insert posteriorly and slide the posterior tabs into the posterior undercuts of the tibial base.The fixed bearing tibial insert is impacted into place on the tibial base, using the fixed bearing insert impactor.Position the impactor at approximately 60 degrees on the insert so that the notch rests on the anterior edge of the center of the insert.Use a mallet to strike the fixed bearing insert impactor".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.The overall complaint was confirmed as the observed condition of the attune cr fb insrt sz 5 5mm 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 j&j 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 was performed for the finished device product code: 151620505 lot number: m6646w, and no non-conformances or manufacturing irregularities were identified.

• Brand Name: ATTUNE CR FB INSRT SZ 5 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: 22167345
• Report Number: 1818910-2025-09314
• Device Sequence Number: 18132077
• Product Code: JWH
• UDI-Device Identifier: 10603295045649
• UDI-Public: (01)10603295045649(17)290531(10)M6646W
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K101433
• 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

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: 151620505
• Device Lot Number: M6646W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 06/10/2025; 06/12/2025; 06/13/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 06/11/2025; 06/13/2025; 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2024
• 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: ATTUNE CR FB INSRT SZ 5 5MM.
• Patient Sex: Unknown