REFLECTION, MICROSTABLE 71742858Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010232281), received between May 31, 2019 and Dec 20, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 2022Material Erosion; Material Erosion

  IT WAS REPORTED THAT, AFTER A THA CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S RIGHT HIP ON (B)(6) 2000 , THE PATIENT EXPERIENCED PAINFUL HARDWARE WITH HIP INSTABILITY. A COMPLEX REVISION SURGERY WAS PERFORMED ON (B)(6) 2010. DURING THIS PROCEDURE, THE ACETABULAR COMPONENTS AND THE FEMORAL HEAD WERE EXPLANTED AND REPLACED WITH AN R3-THA CONSTRUCT. INTRAOPERATIVELY, SIGNIFICANT POLYETHYLENE WEAR WITH LYSIS WAS ENCOUNTERED. THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT COMPLICATIONS AND WAS SUBSEQUENTLY ADMITTED FOR INPATIENT REHABILITATION ON (B)(6) 2010.

  Patient problems: Failure of Implant; Implant Pain; Joint Laxity; Osteolysis

  MAUDE report 16018574 ↗
• InjuryDec 28, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT, AFTER A THA HAD BEEN PERFORMED, A REVISION SURGERY WAS DONE ON (B)(6) 2021 TO EXCHANGE A REF LNR 28X 58-60 20DG SZ G DUE TO WEAR. AS A CONSEQUENCE OF THE LINER REMOVAL, THE COCR 12/14 FEM HEAD 28 -3 WAS REMOVED TOO. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13094998 ↗
• InjuryAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO STANDARD POLYETHYLENE EXCHANGE. ANOTHER S&N DEVICE WAS IMPLANTED. NO OTHER COMPLICATIONS WERE REPORTED AT THIS TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10472483 ↗
• InjuryMay 31, 2019Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PERI-PROTHETIC FRACTURE. HEAD AND LINER WERE REPLACED. DEVICES WON'T BE RETURNED.

  Patient problems: Injury

  MAUDE report 8660078 ↗