MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US C STEM VOID CENTALIZER 12 DM; CEMENT CENTRALIZER/PLUG

Catalog Number	961212500
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that when placing the centralizer on the stem it broke.No fragments were generated.Another implant was used.There was a five minutes of surgical delay.The procedure was successfully completed.There was no patient consequence.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Product description:- c stem void centralizer 12 dm.Product code:- 961212500.Lot no:- 4517670.Quantity of manufactured:- (b)(4).Date of manufacturing:- 11-jul-2024.Expiry date:- 30-jun-2029.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: product description:- c stem void centralizer 12 dm.Product code:- 961212500.Lot no:- 4517670.Quantity of manufactured:- (b)(4).Date of manufacturing:- 11-jul-2024.Expiry date:- 30-jun-2029.Device history review: a manufacturing record evaluation was performed for the finished device, and no non-conformances / manufacturing irregularities related to the malfunction were identified.

• Brand Name: C STEM VOID CENTALIZER 12 DM
• Common Device Name: CEMENT CENTRALIZER/PLUG
• 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 46582
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21247575
• Report Number: 1818910-2025-01574
• Device Sequence Number: 8606165
• Product Code: JDI
• UDI-Device Identifier: 10603295235736
• UDI-Public: (01)10603295235736(17)290630(10)4517670
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• PMA/510(K) Number: K013350
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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

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: 961212500
• Device Lot Number: 4517670
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2024
• 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: Male