MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM RT SZ 7 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Catalog Number	150400207
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the lifting tab on the inner blister lid became detached and therefore it was not possible to transfer the inner blister containing the implant into the sterile field.Another implant was opened for use.There was no patient consequence.There was no surgical delay.
Additional Manufacturer Narrative
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 j&j medtech, or its employees that the report constitutes an admission that the product, j&j medtech, 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 Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.According to the information received, ¿the lifting tab on the inner blister lid became detached and therefore they couldn¿t transfer the inner blister containing the implant into the sterile field¿.Product description:- attune cr fem rt sz 7 cem.Product code:- 150400207.Lot no:- 4506339.Quantity of manufactured:- (b)(4).Date of manufacturing:- 06-jul-2024.Expiry date:- 30-jun-2034.Ifu reference:- 090200828.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot = > product description:- attune cr fem rt sz 7 cem.Product code:- 150400207.Lot no:- 4506339.Quantity of manufactured:- (b)(4).Date of manufacturing:- 06-jul-2024.Expiry date:- 30-jun-2034.Ifu reference:- 090200828.Device history review = > a manufacturing record evaluation was performed for the finished device, and no non-conformances / manufacturing irregularities related to the malfunction were identified.Corrected: h4.

• Brand Name: ATTUNE CR FEM RT SZ 7 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• 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: 21997736
• Report Number: 1818910-2025-07568
• Device Sequence Number: 9504877
• Product Code: JWH
• UDI-Device Identifier: 10603295041221
• UDI-Public: (01)10603295041221(17)20340630(10)4506339
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P830055
• 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

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: 150400207
• Device Lot Number: 4506339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2024
• 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
• Patient Sex: Unknown