SPECTRON 71312112Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010195579), received between Sep 19, 2017 and Jan 24, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 24, 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" 144 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 18577262 ↗
• InjuryFeb 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR THAT HAD BEEN PERFORMED ON 2003, THERE WAS A REVISION SURGERY TO ADDRESS AN UNSPECIFIED EVENT. THE SPEC EF PRIM HO 12/14 SZ 2 WAS EXPLANTED. THE CURRENT STATUS OF PATIENT¿S HEALTH IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11373517 ↗
• InjuryAug 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN AND BONE LOSS.

  Patient problems: Pain

  MAUDE report 8904438 ↗
• InjurySep 19, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED A REVISION HIP SURGERY WAS PERFORMED DUE TO FEMORAL PAIN AND LOOSENING OF STEM, THE LINER WAS ALSO EXCHANGED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 6877895 ↗