MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; RSP, PRIMARY HUMERAL MONOBLOCK, 6MM X 108

Catalog Number	510-00-006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number 1644408-2021-00582; 510-00-012, s809 - trauma, s801 - device cracked/broke, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.
Event or Problem Description
Revision surgery - due to rsp - revision due to stem breakage.

• Brand Name: DJO SURGICAL
• Common Device Name: RSP, PRIMARY HUMERAL MONOBLOCK, 6MM X 108
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: stacey bonnell ; 9800 metric blvd; austin, TX 78758 ; 5128346313
• MDR Report Key: 21723920
• Report Number: 1644408-2025-00357
• Device Sequence Number: 3784075
• Product Code: KWS
• UDI-Device Identifier: 00888912024792
• UDI-Public: 00888912024792
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K100741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/16/2022
• Device Catalogue Number: 510-00-006
• Device Lot Number: 977F1127
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2016
• 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: 506-03-118 LOT: 832C1519.; 506-03-122 LOT: 833C1519.; 506-03-122 LOT: 833C1519.; 506-03-126 LOT: 834C1551.; 508-01-440 LOT: 924F1032.; 508-32-104 LOT: 866C2611.; 508-40-101 LOT: 875C1131.; 510-08-000 LOT: 142G1276.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 114 KG