MAUDE Adverse Event Report: PINN SECTOR W/GRIPTION 50MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121732050

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 02/07/2024

Event Type  Injury  

Event Description

The patient underwent revision as the cup was vertical and needed revising.Surgical delay was unknown.Doi: unknown.Dor: (b)(6) 2024.Affected side: left hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not perform.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 the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.H6: component code: appropriate term/code not available (g07002) used to capture no findings available.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.

• Brand Name: PINN SECTOR W/GRIPTION 50MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• MDR Report Key: 18717932
• MDR Text Key: 335523032
• Report Number: 1818910-2024-03458
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K093646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Type of Report: Initial
• Report Date: 02/15/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 121732050
• Device Lot Number: 9188571
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ALTRX +4 10D 32IDX50OD.; APEX HOLE ELIM POSITIVE STOP.; ARTICUL/EZE BALL 32 +1 GR.; PINN CAN BONE SCREW 6.5MMX25MM.; PINN CAN BONE SCREW 6.5MMX25MM.
• Patient Outcome(s): Required Intervention