MAUDE Adverse Event Report: STRYKER GMBH INTERPROSTHETIC FEMUR PLATE, RIGHT PANGEA PERIPRO FEMUR PLATING SYSTEM 402MM; PLATE, FIXATION, BONE

Catalog Number	627849
Medical Device Problem Codes	Break (1069); Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a distal femur plate failed.The surgeon reports that there was nothing remarkable about the implantation of the device.When asked if the torque limiter was used, he said he couldn¿t not recall for this specific case ¿but does use the torque limiter¿.He also reports that this event occurred around 8 weeks post-op.
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 on a supplemental report.
Event or Problem Description
It was reported that a distal femur plate failed.The surgeon reports that there was nothing remarkable about the implantation of the device.When asked if the torque limiter was used, he said he couldn¿t not recall for this specific case ¿but does use the torque limiter¿.He also reports that this event occurred around 8 weeks post-op.
Additional Manufacturer Narrative
Please note the corrections to d1, d4 catalog number and h6 device code.The plate was not returned for inspection.The reported event could be confirmed based on the x-rays and the photos provided.The locking holes of the distal part of the implant are worn out, as a result of the implantation and loosening/removal of the screws.Nonetheless, the photos received did not enable any other statement and the return of the plate would have been necessary for a complete investigation.The x-rays received were shown to a medical expert, who stated: the x-rays are not sufficient to judge the case and the quality is not that good either.I am wondering are there any screws on the proximal end of the plate at all? it is a long plate and i only see screw in the actual fracture area?? not sure what the biomechanical idea behind the construct is, it is not a bridging plate, or i am missing the screws proximally.I have serious doubt about the construct stability and with a patient not being compliant that may have resulted in trouble.Based on the provided information, the root cause of the reported event is multi-factorial: the location of the fracture and the technical aspects of the surgical procedure may have contributed to the event.Furthermore, patient activity levels post-op, co-morbidities may also have contributed to an inadequate load distribution, and therefore the failure of the construct." based on the investigation, the root cause was attributed to a combination of user and patient condition related issue.The lack of stability of the construct and a potential inadequate implantation technique, combined with the fracture location most probably contributed to the implant loosening.It must be added that patient post-op activities and co-morbidities may also have contributed, nonetheless, such statement could not be confirmed based on the imaged received.The catalog number of the device was not communicated and was not visible on the photos received, nonetheless, it could be determined based on the plate length shown in the pictures.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.

• Brand Name: INTERPROSTHETIC FEMUR PLATE, RIGHT PANGEA PERIPRO FEMUR PLATING SYSTEM 402MM
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20546567
• Report Number: 0008031020-2024-00608
• Device Sequence Number: 7828005
• Product Code: HRS
• UDI-Device Identifier: 07613327414653
• UDI-Public: 07613327414653
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K222381
• 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): 01/08/2025

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: 627849
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 01/08/2025
• 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: Required Intervention
• Patient Sex: Unknown