MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY, INC CABLE-READY® CABLE GRIP SYSTEM, GREATER TROCHANTERIC REATTACHMENT (GTR) DEVICE; INTEGRAL LONG GREATER TROCHANTERIC REATTACHMENT DEVICE (GTR) W/4 CABLES, 23X121M

Model Number	00-2232-002-05
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial left hip arthroplasty on (b)(6) 2024.Subsequently, the patient was revised due to infection on (b)(6) 2025.The cpt femoral stem, cables, and avantage acetabular components were all removed and replaced.
Additional Manufacturer Narrative
The complaint was investigated and evaluated with the information provided.The infection was identified post-operatively and resulted in construct revision of the gtr implant and other devices not manufactured by resolve surgical technologies.The source of infection is potentially related to the implant, but a causal relation cannot be identified with the current information or further testing.A device evaluation was unable to be conducted, as the impacted device is not available for return after it was explanted.No product malfunction has been identified.The device, along with other devices in the construct not manufactured by resolve, was removed during revision surgery for a post-operative infection.A dhr review was conducted confirming no nonconformities or scrap were identified during production.The certificate of sterilization from the subcontract sterilizer confirms that the product was properly exposed to gamma irradiation for an absorbed dose of 27.2-35.4 kgy.The lot met specifications and release requirements at the time of shipment.A historical data analysis was conducted that returned no trends or capas related to this event.The root cause cannot be established with the information currently available.

• Brand Name: CABLE-READY® CABLE GRIP SYSTEM, GREATER TROCHANTERIC REATTACHMENT (GTR) DEVICE
• Common Device Name: INTEGRAL LONG GREATER TROCHANTERIC REATTACHMENT DEVICE (GTR) W/4 CABLES, 23X121M
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY, INC; 375 river park circle; marquette MI 49855
• Manufacturer (Section G): PIONEER SURGICAL TECHNOLOGY, INC; 375 river park circle; marquette MI 49855
• Manufacturer Contact: timothy kolesar ; 375 river park circle; marquette, MI 49855
• MDR Report Key: 23634084
• Report Number: 1833824-2025-00029
• Device Sequence Number: 9336810
• Product Code: KTT
• UDI-Device Identifier: 00846468064051
• UDI-Public: 00846468064051
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K000734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/24/2025

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 Model Number: 00-2232-002-05
• Device Lot Number: 56719952
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/14/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 50 KG