MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 6 POR; ATTUNE CEMENTLESS IMPLANTS : KNEE TIBIAL TRAY

Catalog Number	150611006
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on an unknown date when opening attune tibial base porocoat rp implant there was in issue with the device.Took plastic cover off then opened cardboard box.Took double layered plastic container out and found the hard plastic looked warped - as if it had been overheated.Still sterile, so nurse took first layer paper cover off but scrub nurse had difficulty lifting the 2nd container out of the 1st one.Surgeon took over from scrub nurse and used a blade to slice through the 2nd paper cover.Then used forceps to lift the paper off and another set of forceps to lift out the tibial implant.Following this, both myself and the circulating nurse attempted to separate the two plastics containers without success.No surgical delay.Procedure completed successfully.
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.B3: unknown event date.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.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 and states that: was there any surgical delay related to the event? no.
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 that 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.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Upon further review, the reported event is no longer considered reportable to the usfda as the sterility barrier was not reported to have been breached nor was a direct protective component difficult to remove.No further reports will be submitted under.

• Brand Name: ATTUNE RP TIB BASE SZ 6 POR
• Common Device Name: ATTUNE CEMENTLESS IMPLANTS : KNEE TIBIAL TRAY
• 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: 20634937
• Report Number: 1818910-2024-23328
• Device Sequence Number: 15309072
• Product Code: NJL
• UDI-Device Identifier: 10603295416289
• UDI-Public: (01)10603295416289(17)340531(10)4493214
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• 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: 150611006
• Device Lot Number: 4493214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 11/12/2024; 11/12/2024; 11/26/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 11/12/2024; 11/13/2024; 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2024
• 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