MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 58MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121732058
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
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 a 58 n liner was opened for a 58 cup.Surgeon positioned it with a tonsil and impacted.Checked for stability again with tonsil.Liner did not seat.Repositioned and impacted, the liner would not seat.Implant boxes were checked and after determining the right implant was opened, an identical liner was placed on the field and impacted.Everything went accordingly and surgery carried on.The surgery was successfully completed with 5min of surgical delay.Doi: (b)(6) 2023.Affected side: unknown hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A manufacturing record evaluation was performed for the finished device product code - 121732058,, lot number - 4209798, and no non-conformances / manufacturing irregularities were identified.Product code 121732058, work order (b)(4) pinn sector w/gription 58mm ((b)(4) parts) was manufactured on 02-jul-2023.Parts were manufactured per specification and all raw materials met specification.Scrap: one part from this lot was scrapped: scrap code a090: this concerns ¿handling/ impact damage scrap¿.There is no correlation between this scrap reason and the failure mode of the complaint.Reprocessing: there was no material reprocessing reports (mrr) associated with this lot.Non-conformance: there is zero non-conformances associated with this lot.No deviations or anomalies have been identified during the review of lot 4209798 that would be related to the reported event (b)(4).Complaint confirmation: non-verifiable.Conclusion: due to no similar failures found in the dhr review, the root cause of the complaint cannot be determined.Should further information come available that impacts the findings in this investigation it will be reopened.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 : a manufacturing record evaluation was performed for the finished device product code - 121732058,, lot number - 4209798, and no non-conformances / manufacturing irregularities were identified.

• Brand Name: PINN SECTOR W/GRIPTION 58MM
• 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18028287
• Report Number: 1818910-2023-21886
• Device Sequence Number: 6833889
• Product Code: KWA
• UDI-Device Identifier: 10603295010333
• UDI-Public: 10603295010333
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K093646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2023

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: 121732058
• Device Lot Number: 4209798
• 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: 10/16/2023
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2023
• 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: ALTRX NEUT 36IDX58OD
• Patient Sex: Unknown