MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 50MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121722050
Medical Device Problem Codes	Off-Label Use (1494); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
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 september 5, 2024, the patient underwent a surgery via tha.During the surgery, a nurse noticed a little black substance adhered on the implant when he/she was opened the implant.The surgeon could not confirm the adhered substance.When the assistant surgeon touched the substance with his/her hand, it was removed.Therefore, the implant was washed and used in the surgery.The surgery was completed successfully with no 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.Product code 121722050, work order (b)(4) was manufactured on 06-jun-2024.(b)(4) parts were manufactured per specification and all raw materials met specification.Scrap: there was no scrap associated with this lot.Reprocessing: there was no material reprocessing reports (mrr) associated with this lot.Non-conformance: there were 02 non-conformances associated with this lot.(b)(4) is related to the disposition requirements related to capa-013455: documentation of failing cmm (coordinate measuring machine) results to be generated during incoming, in-process and final inspections.There is no correlation between this non-conformance and the failure mode of the complaint.(b)(4) is related to the calibration fail for tank temperature and the failure mode relates to the cleaning of the product.There is correlation between the nc and the failure mode but there is no risk.To the product.(b)(4) confirms that there is no risk to product as the temperature is still within validated state.Complaint confirmation: non-verifiable.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.

• Brand Name: PINNACLE SECTOR II CUP 50MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• 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: 20236918
• Report Number: 1818910-2024-19476
• Device Sequence Number: 8043104
• Product Code: LPH
• UDI-Device Identifier: 10603295009818
• UDI-Public: (01)10603295009818(17)340531(10)4475565
• 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
• Report Date (Section B): 09/17/2024

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: 121722050
• Device Lot Number: 4475565
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 11/28/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 11/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2024
• 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