PRO 425985SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327544015), received between May 14, 2025 and May 14, 2025 — classified as 3 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED A STRYKER COLLABORATIVE STUDY (SCS) NAMED "A POST-MARKET CLINICAL EVALUATION OF THE TREATMENT OF PELVIS FRACTURES WITH THE PELVIS NEXT GENERATION PLATES OF THE PRO IMPLANTS SYSTEM" THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF PRO PELVIS NEXT GENERATION IMPLANTS. RETROSPECTIVE ANALYSIS WAS CONDUCTED USING THE CLINIC DOCUMENTS AND RADIOGRAPHIC IMAGES OF CASES AT UAB FROM JANUARY 2024- DECEMBER 2024. DURING THE REVIEW OF THE REPORT, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, THE FOLLOWING ADVERSE EVENT WAS REPORTED: PATIENT 15 WAS DIAGNOSED WITH FEMORAL HEAD NECROSIS AT 45 DAYS POST-OPERATIVELY. THIS ADVERSE EVENT WAS CATEGORIZED AS SEVERE BUT DID NOT REQUIRE REVISION SURGERY AT THE TIME OF REPORTING. THE EVENT WAS DETERMINED TO BE POSSIBLY RELATED TO BOTH THE DEVICE AND THE PROCEDURE AND REMAINS ONGOING. THIS PATIENT IS SCHEDULED FOR A THA IN THE NEAR FUTURE.

  Patient problems: Necrosis

  MAUDE report 22019790 ↗
• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED A STRYKER COLLABORATIVE STUDY (SCS) NAMED "A POST-MARKET CLINICAL EVALUATION OF THE TREATMENT OF PELVIS FRACTURES WITH THE PELVIS NEXT GENERATION PLATES OF THE PRO IMPLANTS SYSTEM" THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF PRO PELVIS NEXT GENERATION IMPLANTS. RETROSPECTIVE ANALYSIS WAS CONDUCTED USING THE CLINIC DOCUMENTS AND RADIOGRAPHIC IMAGES OF CASES AT UAB FROM JANUARY 2024- DECEMBER 2024 DURING THE REVIEW OF THE REPORT, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, THE FOLLOWING ADVERSE EVENT WAS REPORTED: PATIENT 15 WAS DIAGNOSED WITH FEMORAL HEAD NECROSIS AT 45 DAYS POST-OPERATIVELY. THIS ADVERSE EVENT WAS CATEGORIZED AS SEVERE BUT DID NOT REQUIRE REVISION SURGERY AT THE TIME OF REPORTING. THE EVENT WAS DETERMINED TO BE POSSIBLY RELATED TO BOTH THE DEVICE AND THE PROCEDURE AND REMAINS ONGOING. THIS PATIENT IS SCHEDULED FOR A THA IN THE NEAR FUTURE.

  Patient problems: Necrosis

  MAUDE report 22019651 ↗
• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED A STRYKER COLLABORATIVE STUDY (SCS) NAMED "A POST-MARKET CLINICAL EVALUATION OF THE TREATMENT OF PELVIS FRACTURES WITH THE PELVIS NEXT GENERATION PLATES OF THE PRO IMPLANTS SYSTEM" THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF PRO PELVIS NEXT GENERATION IMPLANTS. RETROSPECTIVE ANALYSIS WAS CONDUCTED USING THE CLINIC DOCUMENTS AND RADIOGRAPHIC IMAGES OF CASES AT UAB FROM JANUARY 2024- DECEMBER 2024 DURING THE REVIEW OF THE REPORT, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, THE FOLLOWING ADVERSE EVENT WAS REPORTED: PATIENT 1 DEVELOPED A SEVERE INFECTION WITH DISLOCATION 26 DAYS POST-OPERATIVELY, NECESSITATING A SECONDARY OPERATION CONSISTING OF IRRIGATION AND DEBRIDEMENT (I&D), HARDWARE REMOVAL (HWR), AND A GIRDLESTONE PROCEDURE LEADING TO NONUNION. THIS EVENT WAS DEEMED POSSIBLY RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE, ULTIMATELY RESULTING IN PERMANENT DISABILITY.

  Patient problems: Subluxation; Unspecified Infection

  MAUDE report 22019540 ↗