SPECTRON 71312113Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010195586), received between Jan 17, 2018 and Jan 25, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 25, 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" 108 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, AND OSTEOLYSIS. 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: Inadequate Osseointegration; Osteolysis

  MAUDE report 18577308 ↗
• InjuryFeb 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER LEFT THR PERFORMED ON (B)(6) 2021, THE PATIENT PRESENTED AN INFECTION WITH PREVIOUS PELVIC FRACTURE. THIS WAS ADDRESSED VIA REVISIONS SURGERY ON (B)(6) 2022. PATIENT CURRENT STATUS IS UNKNOWN.

  Patient problems: Hip Fracture; Unspecified Infection

  MAUDE report 13517560 ↗
• InjuryDec 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY, THE PATIENT PRESENTED AN INFECTION, SO A FIRST STAGE REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO REMOVE AND REPLACE AN UNKNOWN REFLECTION LINER ((B)(4)), A SPECTRON EF PRIMARY HIGH OFFSET 12/14 FEM SZ 3 ((B)(4)), A COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0 ((B)(4)) AND A REFLECTION THREE HOLE SHELL SIZE 52MM ((B)(4)). CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 13080890 ↗
• InjuryJan 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM SEPTICEMIA AND THE PROSTHESIS HAD TO BE REMOVED AS FIRST STAGE REVISION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7202415 ↗