MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 60MM; HIP METAL ACETABULAR CUP

Catalog Number	121722060
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	06/25/2024
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 on (b)(6) 2024, the patient underwent the surgery via tha for femoral head necrosis for the hip joint.When the inside (clean side) of the double sterilization of the product in question was opened, the part of the cover that opens was sticking out.Therefore, the inner cover was also opened in the unclean area, and the cleanliness nurse directly picked up the product in question.The surgery was completed successfully without any surgical delay.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.It was reported that on (b)(6) 2024, the patient underwent the surgery via tha for femoral head necrosis for the hip joint.When the inside (clean side) of the double sterilization of the product in question was opened, the part of the cover that opens was sticking out.Therefore, the inner cover was also opened in the unclean area, and the cleanliness nurse directly picked up the product in question.The surgery was completed successfully without any surgical delay.No further information is available.Product code: 121722060; lot number: 8126756; manufacturing date: 08-jun-2015.Expiration date: 31-may-2025.Quantity : (b)(4).(b)(4) is related to the conveyor speed on (b)(4) was outside of its required range.Based on the risk assessment completed in attachment "(b)(4) use as is technical justifcation.Pdf" it can be concluded that all product processed through the asset (b)(4) under out of specification parameter may be dispositioned as 'use as is' as the conveyer speed was identified as a non-critical parameter and all product processed through the shrink wrap is subject to 100% inspection as per normal processing requirements.There is no correlation between this non- conformance and the failure mode of the complaint.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.
Event or Problem Description
Was there any patient harm related to the event?: no.Was there any surgical delay related to the event?: no.
Additional Manufacturer Narrative
Product complaint # (b)(4).Upon further review, the reported event did not involve a product that was delivered as unsterile.The outer package was difficult to open which is not considered a reportable malfunction at this time.No patient injury or harm occurred as a result of the difficult to open package.

• Brand Name: PINNACLE SECTOR II CUP 60MM
• Common Device Name: HIP METAL ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 19645135
• Report Number: 1818910-2024-14383
• Device Sequence Number: 6632775
• Product Code: MRA
• UDI-Device Identifier: 10603295009863
• UDI-Public: (01)10603295009863(10)8126756(17)250531
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P070026
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2024

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 Expiration Date: 05/31/2025
• Device Catalogue Number: 121722060
• Device Lot Number: 8126756
• 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: 06/25/2024
• Supplement Date Received by Manufacturer: 09/03/2024; 09/03/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 09/03/2024; 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2015
• 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 Age: 48 YR
• Patient Sex: Male