SPECTRON 71312114Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010195593), received between Mar 31, 2019 and Mar 17, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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. 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.

• InjuryMar 17, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, 7 YEARS AFTER A PRIMARY LEFT THR SURGERY HAD BEEN PERFORMED WITH AN R3/SYNERGY CONSTRUCT, THE PATIENT EXPERIENCED LOOSENING OF THE CEMENTED SPEC EF PRIM HO 12/14 SZ 4. THIS ADVERSE EVENT WAS ADDRESSED BY A REVISION LEFT THR ON (B)(6) 2022, WHERE IT WAS NOTICED THE STEM TO BE GROSSLY LOOSE. IN ADDITION TO THE STEM, THE HEAD AND LINER WERE ALSO EXPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13794681 ↗
• InjuryApr 2, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD A LEFT SIDE THA AT (B)(6), (B)(6) 2019 WITH A SPECTRON/ POLARCUP CONSTRUCT VIA A POSTERIOR APPROACH. PATIENT HAS MEDICAL HISTORY OF KIDNEY TRANSPLANT. PATIENT LEFT HIP WOUND WOULD NOT HEAL AND WAS INFECTED. PATIENT HAD A WASHOUT AND DEBRIDEMENT (DONE BY ANOTHER SURGEON) AS WELL AS VAC DRESSINGS, PRIOR TO FIRST STAGE REVISION ON (B)(6) 2019. DR. PERFORMED FIRST STAGE REVISION HIP SURGERY ON (B)(6) 2019 REMOVING ACETABULAR IMPLANTS WITH ZIMMER EXPLANT AND USING RENOVATION HIP TO REMOVE FEMORAL COMPONENT. SURGEON PERFORMED AN ETO AND REMOVED CEMENT FROM FEMUR WITH RENOVATION INSTRUMENTS. ACETABULUM REAMED AND FEMUR REAMED. WOUND DEBRIDED AND IRRIGATED WITH SALINE AND BETADINE AND FEMUR CABLED WITH CIRCLAGE WIRE TEMPORARILY. WOUND CLOSED, AND THEN PT RE-PREPPED AND DRAPED WITH WHOLE NEW SETUP. PT THEN REOPENED AND THEN DALLMILES CABLES APPLIED TO FEMUR AND ZB HIP CEMENT SPACER INSERTED WITH PALACOS COPAL CEMENT LOADED WITH ANTIBIOTIC USED TO FIX HIP CEMENT SPACER. WOUND IRRIGATED AND CLOSED IN LAYERS.

  Patient problems: Unspecified Infection

  MAUDE report 8475267 ↗
• InjuryMar 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2019. PATIENT LEFT HIP WOUND WOULD NOT HEAL AND WAS INFECTED. PATIENT HAD A WASHOUT AND DEBRIDEMENT PRIOR TO FIRST STAGE REVISION ON (B)(6) 2019, ACETABULAR IMPLANTS AND FEMORAL COMPONENT WERE REMOVED. ANTIBIOTIC CEMENT SPACER IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 8468043 ↗