Simplex 6188-1-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327128437), received between Sep 25, 2017 and Nov 27, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 27, 2024Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS RIGHT HIP ON OR ABOUT (B)(6) 2008 AND WAS REVISED ON (B)(6) 2010. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE(S) AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. AS PER MEDICAL REVIEW: "THE IMPLANT RECORD AND OPERATIVE REPORT CONFIRM A REVISION THA WAS PERFORMED FOR LOSS OF ACETABULAR FIXATION WITH CHANGE IN COMPONENT POSITION IN A CEMENTED THA. NO DOCUMENTATION WAS PROVIDED REGARDING INCREASED METAL ION LEVELS." MEDICAL RECORD: "[...] FOLLOWUP RADIOGRAPH OF THE HIP WAS OBTAINED AND THERE WAS OBVIOUS CHANGE IN POSITION OF THE ACETABULAR COMPONENT WITH LOSS OF FIXATION OF THE CEMENT. [...]".

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 20799124 ↗
• InjuryAug 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE ATTORNEY, THROUGH THE FILING OF A LAWSUIT, THAT THE PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009 WHERE SHE WAS IMPLANTED WITH A COMPETITOR HIP RESURFACING SYSTEM. IT IS FURTHER ALLEGED THAT HER HIP SYSTEM FAILED AND REQUIRED REVISION OF THE FEMORAL AND TIBIAL COMPONENTS ON (B)(6) 2016. UPDATE 10-AUG-2018: LEGAL DEPARTMENT CONFIRMED THAT THE ONLY STRYKER PRODUCT INVOLVED IN THIS EVENT IS SIMPLEX BONE CEMENT. THE MENTION OF TIBIAL COMPONENT WAS CONFIRMED TO BE AN ERROR. ON (B)(6) 2018- LEGAL DEPARTMENT CONFIRMED THAT THE PATIENT DID NOT HAVE A KNEE SURGERY NOR ANY STRYKER KNEE IMPLANT.

  Patient problems: Injury

  MAUDE report 7774003 ↗
• MalfunctionSep 25, 2017Break; Break

  GLASS AMPOULE BODY FROM SIMPLEX P HALF DOSE BROKE INTO MULTIPLE PIECES WHILE OPENING. SURGICAL TECH STATED THAT HE PLACED ONE HAND ON THE AMPOULE BODY AND PLACED HIS OTHER HAND ON THE POLYETHYLENE SLEEVED TIP. WHILE ATTEMPTING TO OPEN THE AMPULE THE GLASS BODY "EXPLODED" INTO PIECES. THE GLASS AMPOULE WAS NOT WRAPPED IN A STERILE GAUZE AS RECOMMENDED IN THE TECHNIQUE GUIDE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6891956 ↗