SPECTRON 71312103Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010195531), received between Jan 17, 2024 and Jan 22, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 reports).

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. How this data works · Data updated Oct 13, 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.

• InjuryJan 22, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT ON LITERATURE REVIEW "INFLAMMATORY TISSUE REACTIONS AROUND ASEPTICALLY LOOSE CEMENTED HIP PROSTHESES: A RETRIEVAL STUDY OF THE SPECTRON EF STEM WITH REFLECTION ALL-POLY ACETABULAR CUP" 39 MONTHS AFTER A THA SURGERY, WHERE AN SPECTRON EF STEM AND A REFLECTION NON-CROSSLINKED ALL-POLLY CUP WERE IMPLANTED, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO LOOSENING OF THE CUP AND THE STEM. THE STUDY DETERMINED THAT BOTH THE STEM AND THE CUP WERE WORN, ADDITIONALLY PE, CR, CO AND ZN PARTICLES WERE PRESENT IN THE PERIPROSTHETIC TISSUE. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18557394 ↗
• InjuryJan 17, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT ON LITERATURE REVIEW "INFLAMMATORY TISSUE REACTIONS AROUND ASEPTICALLY LOOSE CEMENTED HIP PROSTHESES: A RETRIEVAL STUDY OF THE SPECTRON EF STEM WITH REFLECTION ALL-POLY ACETABULAR CUP" 214 MONTHS AFTER A THA SURGERY, WHERE AN SPECTRON EF STEM AND A REFLECTION NON-CROSSLINKED ALL-POLLY CUP WERE IMPLANTED, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO LOOSINNG OF THE CUP AND THE STEM, AND A FRACTURE OF THE FEMUR. THE STUDY DETERMINED THAT BOTH THE STEM AND THE CUP WERE WORN, ADDITIONALLY PE, CR, CO AND ZR PARTICLES WERE PRESENT IN THE PERIPROSTHETIC TISSUE. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 18531915 ↗
• InjuryJan 17, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT ON LITERATURE REVIEW "INFLAMMATORY TISSUE REACTIONS AROUND ASEPTICALLY LOOSE CEMENTED HIP PROSTHESES: A RETRIEVAL STUDY OF THE SPECTRON EF STEM WITH REFLECTION ALL-POLY ACETABULAR CUP" 155 MONTHS AFTER A THA SURGERY, WHERE AN SPECTRON EF STEM AND A REFLECTION NON-CROSSLINKED ALL-POLLY CUP WERE IMPLANTED, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO LOOSINNG OF THE CUP AND THE STEM, AS WELL AS OSTEOLYSIS AND FRACTURE OF THE FEMUR. THE STUDY DETERMINED THAT BOTH THE STEM AND THE CUP WERE WORN, ADDITIONALLY PE, CR, CO AND ZR PARTICLES WERE PRESENT IN THE PERIPROSTHETIC TISSUE. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; Osteolysis

  MAUDE report 18531872 ↗