MAUDE Adverse Event Report: Stryker GmbH GAMMA3 - TROCHANTERIC NAIL KIT, TI D11X200MM X 125DEG; Rod, Fixation, Intramedullary And Accessories

Catalog Number	31251200S
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Nausea (1970); Pain (1994)
Date of Event	01/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that "on (b)(6) 2024: placement of a sterile titanium proximal femoral nail at (b)(6) hospital in le puy-en-velay for a fracture of the right femur.On (b)(6) 2024: episcleritis diagnosed by ophthalmologists.On (b)(6) 2025: diagnosis of erythema nodosum made in the emergency department of (b)(6) due to pain and swelling in the lower extremities, initially treated as erysipelas.Diagnosis of sarcoidosis-type granulomatosis confirmed by lymph node biopsy due to the presentation of episcleritis, erythema nodosum, and mediastinal lymphadenopathy.(b)(6) 2025: initiation of corticosteroid therapy at 0.5 mg/kg/day of prednisolone with gradual tapering over 1 year.During the tapering phases, the patient described the onset of nonspecific symptoms such as: - heaviness in the legs - nausea - pain in the right leg if the patient puts his cell phone in the right pants pocket - asthenia - difficulty concentrating - shortness of breath - sweating - coughing or sneezing when applying alcohol-based deodorant or consuming alcohol.It should be noted that the patient reports a history of reactions to metals: belt buckles, jeans buttons, and costume jewelry around the age of 20; no episodes since then.(b)(6) 2026: removal of the gamma nail on (b)(6) 2026 (b)(6) hospital.All of the symptoms described above have disappeared, including episcleritis, with the exception of joint pain in the operated hip, for which the patient is still undergoing rehabilitation.On (b)(6) 2026: the allergy department (b)(6) hospital diagnosed a strong skin sensitivity to nickel but not to titanium.Skin allergy test (patch test): strong skin sensitivity to nickel (standard european panel) with a history of clinical relevance (reaction to costume jewelry); no sensitivity to the metal implant panel.Current patient status: sarcoidosis with episcleritis, erythema nodosum, and mediastinal lymphadenopathy from (b)(6) 2024 to (b)(6) 2026 (date of titanium pin removal).During the tapering phases of corticosteroid therapy, the patient described the onset of nonspecific symptoms such as: - heaviness in the legs - nausea - pain in the right leg if the patient puts his cell phone in the right pants pocket - asthenia - difficulty concentrating - shortness of breath - sweating - coughing or sneezing when applying alcohol-based deodorant or consuming alcohol.Joint pain in the operated hip, without reduced mobility, decreased postoperative range of motion, or local inflammation.Actions taken at the healthcare facility for the patient¿s care: emergency department care in (b)(6) 2024.Corticosteroid therapy for 1 year in 2025.Removal of the titanium nail in (b)(6) 2026.Allergy testing (patch test) in (b)(6) 2026: strong skin sensitivity to nickel but not to titanium.The device was not retained for expert analysis.".
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.

• Brand Name: GAMMA3 - TROCHANTERIC NAIL KIT, TI D11X200MM X 125DEG
• 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: 25752575
• Report Number: 0008031020-2026-00821
• Device Sequence Number: 10449445
• Product Code: HSB
• UDI-Device Identifier: 04546540375087
• UDI-Public: (01)04546540375087(17)280430(10)K13B23E
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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: 31251200S
• Device Lot Number: K13B23E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2026
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 07/08/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2023
• 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: 49 YR
• Patient Sex: Male