MAUDE Adverse Event Report: Stryker GmbH Gamma3 - Trochanteric Nail Kit, Ti D11x180mm x 120deg; Rod, Fixation, Intramedullary And Accessories

Catalog Number	31201180S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	07/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Ansm reported that: date of occurrence: (b)(6) 2026.Description of the incident: implantation of a gamma 3 nail on (b)(6) 2025, for a left femoral pertrochanteric fracture that had been progressing for one month and was complicated by a consolidated metastatic lesion from prostate cancer.(b)(6) 2026: removal of the gamma nail, following the diagnosis of a left pertrochanteric pseudarthrosis resulting from radiation therapy to the metastases of the lesser trochanter, with fracture of a gamma nail implanted in (b)(6) 2025.Patient¿s current status: revision surgery with removal of the nail and implantation of a total hip prosthesis with dual mobility.Actions taken at the healthcare facility for the patient¿s care: removal of the nail on (b)(6) 2026.".

• Brand Name: Gamma3 - Trochanteric Nail Kit, Ti D11x180mm x 120deg
• Common Device Name: Rod, Fixation, Intramedullary And Accessories
• Manufacturer (Section D): Stryker GmbH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): Stryker Trauma GmbH; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50547353
• Report Number: 0008031020-2026-01448
• Device Sequence Number: 10362306
• Product Code: HSB
• UDI-Device Identifier: 04546540375025
• UDI-Public: 04546540375025
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

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: Lay User/Patient
• Device Catalogue Number: 31201180S
• Device Lot Number: K131AA5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown