MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 7 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151640708
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2024
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 during final implantation of fixed bearing posterior stabilized insert, the insert wouldn't lock into the tibial tray on the anterior side.Surgeon took it out assessed knee for any obstacles that could interfere with fixation of insert, didn¿t found anything and did second attempt to fix insert to tibial tray without success.We have opened another insert in the same size and thickness.It locked without any problem.After the case the problematic insert looked like anterior flange was bent forward and locking appendage couldn¿t sit in designated groove in tibial component.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > there was issue with insertion of attune fixed bearing insert.During final implantation of fixed bearing posterior stabilised insert, insert didn¿t wanted to lock in the tibial tray on the anterior side.Surgeon took it out assessed knee for any obstacles that could interfere with fixation of insert, didn¿t found anything and did second attempt to fix insert to tibial tray without success.We have opened another insert in the same size and thickness.It locked without any problem.After the case i have inspected the problematic insert and it looked like anterior flange was bend forward and locking appendage couldn¿t sit in designated groove in tibial component.¿the product was not returned to depuy synthes, however photos were provided for review.(_external_ re_ (b)(4) additional information (2nd request) & missing device follow up (3rd request)).The photo investigation revealed the locking tab of attune ps fb insrt sz 7 8mm deformed.The observed damage can be consistent with a component failure caused by excessive forces applied over material, like assembling the device in an off axis position during surgical process.Properly handling and¿attention to the approved use of the device diminishes the risk of failure.As per attune¿ revision knee system fixed bearing surgical technique rev.D, on page 213, the next steps need to be follow for a proper implantation of the attune ps/cr insert with the revision 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.Even though a functional test was not performed, it is reasonable to confirm the reported allegation as damage observed on the tab may lead to difficulty on the assembly of device.The overall complaint was confirmed as the observed condition of the attune ps fb insrt sz 7 8mm 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 = > a manufacturing record evaluation was performed for the finished device m4458u number, and no non-conformances nor manufacturing irregularities were identified.H11 additional narrative: corrected: d4 (primary udi number).
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.H10 additional narrative: added: b3, b5, h6 (clinical and impact code).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
Additional information was received: was there a surgical delay? what is the duration of the delay? no there was no delay in the surgery.Was/were there any adverse consequence/s that affected the patient because of the reported event? no there was not.

• Brand Name: ATTUNE PS FB INSRT SZ 7 8MM
• 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
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19380363
• Report Number: 1818910-2024-11354
• Device Sequence Number: 18009002
• Product Code: JWH
• UDI-Device Identifier: 10603295050230
• UDI-Public: (01)10603295050230(17)280731(10)M4458U
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K111433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2024

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: 151640708
• Device Lot Number: M4458U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2024
• Supplement Date Received by Manufacturer: 05/31/2024; 07/17/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 06/04/2024; 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2023
• 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
• Patient Sex: Unknown