MAUDE Adverse Event Report: STRYKER GMBH 3.5 DISTAL MEDIAL FEMUR PLATE, L PANGEA FEMUR PLATING SYSTEM 3.5MM, 124MM/4 HOLE; PLATE, FIXATION, BONE

Catalog Number	540204
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported "a case where a patient experienced hardware failure after the initial operation" revision surgery required.
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
It was reported "a case where a patient experienced hardware failure after the initial operation" revision surgery required.Additional information: plate hardware locking screws became prominent resulting in hwr surgery and eventually a total knee replacement on (b)(6) 2025.
Additional Manufacturer Narrative
Correction: please refer to: b5 executive summary.D9, product available to stryker.H6 (component, method & results code).The reported event was rated as confirmed due to the observed damages at the received devices.The device inspection revealed the following: the distal medial femur plate was returned for evaluation.Several damages could be observed at the universal holes.Two (2) of the distal universal holes are more severely damaged and it is likely that a proper screw locking function was not given anymore in those holes.Based on this is the complaint rated as confirmed although no x-rays or any other evidence was provided, which would confirm the occurrence.The two (2) most distal holes have damaged edges, which indicates a an out of the 30 degree cone contact.All other holes of the plate, are either intact as no screw was inserted or have the typical damages that occur when locking screw or a cortex screw is correctly inserted.The anodized layer is not present anymore at all observed damages, which indicates that the damages were caused post manufacturing.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.The complaint was reviewed by r&d, including a interview with the operating physician, with following result: the complaint was reviewed by r&d, including a interview with the operating physician, with following results: "all holes (3,4,13) where cortex screw seems to have been used, show normal trace of screw contact with the hole & 8 holes shows trace of use of locking screws.Holes 1 and 2 shows normal locking imprints along the edges however they both present trace of wear on portion of the hole not supposed to interfere with the locking screw when inserted within the 30 degree cone holes 11 and especially 12 show imprints damage.Hole 12 had multiple attempt to lock the screw at different angles.Edge reaming could come from screws with poor bone purchase (osteoporotic bone) and trajectory above 15 degrees.It could also be the result of freehand drilling.Less likely screw hitting hardware almost at the time the head starts to lock in the hole we cannot confirm whether drill came in contact with the hole edges or not.Apparently, the procedure was strictly followed involving the use of drill guide that should prevent the drill to contact the hole edges.We cannot tell if the heavy trace of wear outside 30 degree cone are the result of loosed screws or if the traces appeared before mechanism failure on some cortex screw the thread shaft damage witness likelihood of hardware collision locking screws show normal trace of use" no product related issue could be detected during the investigation.Based on the provided information, no pre-, intra- and post-operative x-rays in different planes, operation reports, detailed patient details, history and activity was provided, the root cause of the reported event cannot be defined.There are too many factors, like screw insertion angle and torque, position of other already present implants, fracture situation, patient condition, especially in relation to bone quality and activity, that could have played a role.If more information is provided, the case will be reassessed.

• Brand Name: 3.5 DISTAL MEDIAL FEMUR PLATE, L PANGEA FEMUR PLATING SYSTEM 3.5MM, 124MM/4 HOLE
• 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 ; 2018315000
• MDR Report Key: 22520479
• Report Number: 0008031020-2025-01246
• Device Sequence Number: 15591246
• Product Code: HRS
• UDI-Device Identifier: 07613327610314
• UDI-Public: (01)07613327610314(10)AD3479
• 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 Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• 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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 540204
• Device Lot Number: AD3479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/20/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2023
• 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 Sex: Unknown