MAUDE Adverse Event Report: STRYKER GMBH INTERPROSTHETIC FEMUR PLATE, LEFT PANGEA PERIPRO FEMUR PLATING SYSTEM 358MM; PLATE, FIXATION, BONE

Catalog Number	627842
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "a large fragment pangea peripro interprosthetic plate was used to treat a midshaft periprosthetic femur fracture.Shortly after initial surgery date (b)(6) 2025, the surgeon noticed the most proximal t20 4.0 pangea locking screw was beginning to back out of the plate.The screw sequentially backed out of the locking mechanism at each post operative visit until the screw fully backed out and slid all the way down to her distal femur".Patient had to be brought back into operating room 16 weeks post operatively to remove backed out hardware (now sitting adjacent to the distal femur).
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.

• Brand Name: INTERPROSTHETIC FEMUR PLATE, LEFT PANGEA PERIPRO FEMUR PLATING SYSTEM 358MM
• 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: 23810447
• Report Number: 0008031020-2025-02158
• Device Sequence Number: 15380413
• Product Code: HRS
• UDI-Device Identifier: 07613327413809
• UDI-Public: 07613327413809
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K222381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/15/2025

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: 627842
• 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: 11/17/2025
• Initial Report FDA Received Date: 12/15/2025
• 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 Age: 60 YR
• Patient Sex: Female