MAUDE Adverse Event Report: Stryker GmbH PANGEA FEMUR PLATING DISTAL LATERAL FEMUR PLATE, R 5.0MM, 302MM/12 HOLES; Plate, Fixation, Bone

Catalog Number	540182
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/29/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported: "plate locking screws became prominent after the locking mechanism uncoupled resulting in a lack of stability and hwr surgery.A single distal lateral locking 5.0 screw was visible underneath the plate surface confirming screw tear thru the locking mechanism of the plate.Unusual performance of the locking plate was questioned by the surgeon and patient was then staged with a static spacer with antibiotics on (b)(6) 2026 and then a dfr scheduled a few days later.However, before the patient's dfr they passed away from post-surgical complications related to general health and optimization.".
Event or Problem Description
It was reported: "plate locking screws became prominent after the locking mechanism uncoupled resulting in a lack of stability and hwr surgery.A single distal lateral locking 5.0 screw was visible underneath the plate surface confirming screw tear thru the locking mechanism of the plate.Unusual performance of the locking plate was questioned by the surgeon, and patient was then staged with a static spacer with antibiotics on (b)(6)2026 and then a dfr scheduled a few days later.However, before the patient's dfr they passed away from post-surgical complications related to general health and optimization.".
Additional Manufacturer Narrative
The reported event could be confirmed, since a displacement of four (4) locking screws could be confirmed based on the pictures received.The device inspection revealed the following: the distal lateral femur plate, five (5) locking screws, one (1) cancellous screw and four (4) cortex screws were returned for evaluation.Based on the provided information was there no issue with the bone screws, therefore are the cortex screws and the cancellous screw considered as concomitant devices.The visual inspection of the plate has shown that all distal holes are strongly damaged.The anodized layer is not present anymore at the damage which indicates that they were caused by post-manufacturing.The most damaged hole is the most distal universal hole number.The hole is on one side completely flattened, due to the excessive damage does the screw head fall through the hole.This confirms that this is the hole, where the screw went through the plate, which is also visible on the received x-rays.At all other universal holes are the tips in the bore partially flattened.None of the holes does show the typical signs that are created when a locking screw is properly locked in the hole.All holes have drill marks on one side of the edge on the top side of the plate.The same damages at the drill holes could also be observed at the bottom side of the plate.All holes have drill marks, including a burr, on one side of the bottom edge.Such drill marks at the edges are only possible if drilling is made from the intended 30 degree cone.Based on this finding it can be concluded that the three (3) locking screw that are backed out on the received x-rays were never properly locked in the hole due to the during drilling caused damage at the holes.The inspection of the universal hole in the shaft area, where the shortest received locking screw (40mm) was placed, has shown that this hole has no abnormal damages.The hole has the typical view that is created when a locking screw is properly locked in the plate.This is also visible on the x-rays, where this screw is in the correct locked position in the plate.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required currently.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design-related problems were found during the investigation.No product related issue could be detected during the investigation.Based on investigation, the root cause was most likely attributed to a user related issue, since the visible marks indicate a drilling out of the 30 degree cone of the predetermined hole trajectory of the universal holes.However, the exact root cause could not be defined since no pre- and intraoperative x-rays in different planes, operation reports, detailed patient details, history and activity were provided.There are many factors that could have played a role too, like screw insertion torque, fracture situation, patient condition, especially in relation to bone quality and activity.If more information is provided, the case will be reassessed.

• Brand Name: PANGEA FEMUR PLATING DISTAL LATERAL FEMUR PLATE, R 5.0MM, 302MM/12 HOLES
• Common Device Name: Plate, Fixation, Bone
• Manufacturer (Section D): Stryker GmbH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): Stryker GmbH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 25255962
• Report Number: 0008031020-2026-00686
• Device Sequence Number: 5495681
• Product Code: HRS
• UDI-Device Identifier: 07613327609783
• UDI-Public: (01)07613327609783(10)AK6867
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K242445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• 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: 540182
• Device Lot Number: AK6867
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/27/2026
• 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: 04/29/2026
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2024
• 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: Death; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male