MAUDE Adverse Event Report: STRYKER GMBH LAG SCREW GAMMA4 Ø10.5X90MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81600090S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arthritis (1723); Implant Pain (4561); Bursitis (4832)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "study: stryker pegasus.Subject: (b)(6).Onset date: (b)(6): pain.Patient first left message with internal medicine about painful left hip on (b)(6) 2025.She was seen by the surgeon on (b)(6) 2025.She described diffuse left hip pain radiating down leg and worsened by weightbearing.Assessment at (b)(6) (b)(6) 2025 follow-up included gt bursitis, arthritis, and left si joint pain.She has tried gabapentin and got cortisone injection at this follow-up.She is considering hip replacement surgery.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "study: stryker pegasus.Subject: (b)(4).Onset date: 01-jan-2025 - pain.Patient first left message with internal medicine about painful left hip on (b)(6) 2025.She was seen by the surgeon on (b)(6) 2025.She described diffuse left hip pain radiating down leg and worsened by weightbearing.Assessment at (b)(6) 2025 follow-up included gt bursitis, arthritis, and left si joint pain.She has tried gabapentin and got cortisone injection at this follow-up.She is considering hip replacement surgery.".

• Brand Name: LAG SCREW GAMMA4 Ø10.5X90MM
• 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 KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21806084
• Report Number: 0008031020-2025-00674
• Device Sequence Number: 13005235
• Product Code: HSB
• UDI-Device Identifier: 07613327510928
• UDI-Public: 07613327510928
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

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: Lay User/Patient
• Device Catalogue Number: 81600090S
• Device Lot Number: UNKNOWN
• 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: 03/13/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 05/30/2025
• 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: Other
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 69 KG