MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS FB INSRT SZ 4 8MM; PROSTHESIS, KNEE, CEMENTED, POLYMER/METAL/POLYMER

Catalog Number	151700408
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	10/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6.The product was not returned to medtech orthopaedics, however photos were provided for review.The photo investigation revealed that '151700408, attune crs fb insrt sz 4 8mm had implant bearing wear."potential cause can be attributed to unintended use error by use of excessive force in a prying motion and overload of the material." since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the attune crs fb insrt sz 4 8mm would contribute to the complained device issue.Based on the investigation findings, potential cause can be unintended use error caused or contributed to event 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported on (b)(6) 2024, when removing the inlay and the attune crs femoral component, metallosis appeared on the inlay.Surgery was completed successfully with no surgical delay.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary when removing the inlay and the attune crs femoral component, metallosis appeared on the inlay.The product was not returned to j&j medtech orthopaedics, however photos were provided for review.The photo investigation revealed the attune crs fb insrt sz 4 8mm with signs of extraction, additionally, marks on the reinforcement pin can be seen as expected due to the metal-metal interaction.The observed condition does not represent a device nonconformance.No signs of metal deterioration nor sings of metallosis were observed on the device.The investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.A manufacturing record evaluation was performed for the finished device [151700408/ m1683k] and no non-conformances or manufacturing irregularities were identified.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 not confirmed as the observed condition of the attune crs fb insrt sz 4 8mm would not 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 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 [151700408/ m1683k] and no non-conformances or manufacturing irregularities were identified.H11 additional narrative: added: d10.

• Brand Name: ATTUNE CRS FB INSRT SZ 4 8MM
• Common Device Name: PROSTHESIS, KNEE, CEMENTED, POLYMER/METAL/POLYMER
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20543715
• Report Number: 1818910-2024-22106
• Device Sequence Number: 7872676
• Product Code: JWH
• UDI-Device Identifier: 10603295054702
• UDI-Public: (01)10603295054702(17)281201(10)M1683K
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K160700
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 151700408
• Device Lot Number: M1683K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK ATTUNE FEMORAL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown