Simplex HV 6194-1-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 04260056885747), received between Oct 10, 2016 and Jun 23, 2026 — classified as 76 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (32 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 85 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A TOTAL KNEE REVISION PROCEDURE, THE PATIENT DEVELOPED A POST-OPERATIVE KNEE INFECTION. CONSEQUENTLY, THE EXISTING 3 X 11 REVISION POLY INSERT WAS REMOVED AND REPLACED WITH A NEW 3 X 11 REVISION POLY INSERT.

  Patient problems: Implant Pain; Unspecified Infection

  MAUDE report 25589851 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO FEMORAL PAIN. THE CR FEMORAL COMPONENT AND INSERT WERE REVISED TO A TS FEMORAL COMPONENT AND INSERT. THE SALES REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED IMPLANTS, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Arthralgia

  MAUDE report 24188053 ↗
• MalfunctionJan 12, 2026Device Handling Problem

  BONE CEMENT WAS STILL ADHERING TO THE SURGEON'S GLOVES BUT NOT TO THE PATIENT'S PATELLA. THE REP DOUBLY CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE SETTING TIME OF THE CEMENT. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF LESS THAN 15 MINUTES (TOURNIQUET WAS USED IN THE CASE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24034829 ↗
• InjuryMay 26, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  PATIENT ALLEGES ALLERGIC REACTION AND PENDING REVISION FOR BOTH OF HIS KNEE REPLACEMENTS. THIS REPORT IS FOR THE LEFT KNEE.

  Patient problems: Arthralgia; Hypersensitivity/Allergic reaction

  MAUDE report 22083246 ↗
• InjuryMay 13, 2025Device Handling Problem; Device Handling Problem

  PROBLEMS DURING APPLICATION OF THE BONE CEMENT, THE CEMENT HAS BEEN REMOVED AND REPEATED WITH AN ADDITIONAL UNIT. THE PROBLEM HAS HAPPENED 2 TIMES ON THE SAME DAY, THE IMPLANTATION HAS BEEN FINISHED WITH 15 MINUTES DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22008413 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  PATIENT ALLEGES ALLERGIC REACTION AND PENDING REVISION FOR BOTH OF HIS KNEE REPLACEMENTS.

  Patient problems: Arthralgia; Hypersensitivity/Allergic reaction

  MAUDE report 21932408 ↗
• MalfunctionMar 14, 2025Ambient Temperature Problem; Ambient Temperature Problem

  A SALES REP RECEIVED A CALL A FROM A HOSPITAL STATING THAT HAD A SITUATION WITH SIMPLEX HV CEMENT DURING A ROUTINE TKA WITH DR (B)(6). HE STATED THAT THE CEMENT SET UP REALLY QUICKLY AND HAD TO USE TWO BATCHES/MIXES OF CEMENT TO COMPLETE IMPLANTATION OF TIBIA BP, FEMORAL COMPONENT, AND PATELLA COMPONENT. THE SALES REP SPOKE WITH DR (B)(6) ON THE DAY OF SITUATION AND HE MENTIONED THAT THE ROOM WAS EXTREMELY HOT IN TEMPERATURE DURING THIS CASE. HE ALSO STATED THAT THE MIX TIME ON FIRST BATCH OF CEMENT WAS 45SEC. WHICH SET UP IN 5MIN. A SECOND BATCH OF CEMENT WAS MIXED FOR 30 SEC. WHICH SET UP IN 8MIN WITHOUT PROBLEMS TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21603839 ↗
• InjuryJan 7, 2025Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  PATIENT CALLED THE SUPPLIER TO REPORT THAT THEY HAD A PROCEDURE ON (B)(6) 2023 WITH STRYKER IMPLANTS ON THEIR LEFT KNEE. THEY STATED THAT THEY EXPERIENCED LOOSENING AND SOME OF THE IMPLANT FAILED.

  Patient problems: Arthralgia; Inadequate Osseointegration; Joint Laxity

  MAUDE report 21090810 ↗
• InjuryDec 23, 2024Osseointegration Problem; Osseointegration Problem

  PT. CALLED TO REPORT THAT THEY HAD A PROCEDURE ON (B)(6) 2023 WITH STRYKER IMPLANTS ON THEIR LEFT KNEE. THEY STATED THAT THEY EXPERIENCED LOOSENING AND SOME OF THE IMPLANT FAILED. THEY WOULD LIKE TO FILE A CLAIM. ADDITIONAL INFO. 27-NOV-2024: REVISION ON (B)(6) 2023. DEC 20. 2024- AS PER MEDICAL REVIEW, THE PATIENT WAS REVISED DUE TO TIBIAL LOOSENING AND ROM. AN ADDITIONAL RECORD WAS CREATED FORT HE MUA AFTER REVISION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20999381 ↗
• InjuryDec 23, 2024Osseointegration Problem; Osseointegration Problem

  PT. CALLED TO REPORT THAT THEY HAD A PROCEDURE ON (B)(6) 2023 WITH STRYKER IMPLANTS ON THEIR LEFT KNEE. THEY STATED THAT THEY EXPERIENCED LOOSENING AND SOME OF THE IMPLANT FAILED. THEY WOULD LIKE TO FILE A CLAIM. ADDITIONAL INFO. 27-NOV-2024: REVISION ON (B)(6) 2023. DEC 20. 2024- AS PER MEDICAL REVIEW, THE PATIENT WAS REVISED DUE TO TIBIAL LOOSENING AND ROM. AN ADDITIONAL RECORD WAS CREATED FORT HE MUA AFTER REVISION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20999378 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  REVISION OF RIGHT PARTIAL MEDIAL KNEE REPLACEMENT TO RIGHT TOTAL KNEE REPLACEMENT. REASON FOR REVISION IS DISEASE PROGRESSION TO LATERAL AND PF COMPARTMENTS.

  Patient problems: Arthralgia; Arthritis; Inflammation

  MAUDE report 20512114 ↗
• InjuryOct 16, 2024Loss of Osseointegration; Loss of Osseointegration

  REVISED A RIGHT MEDIAL MCK UNI DUE TO LOOSENING OF BOTH THE FEMUR AND TIBIAL COMPONENTS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20460159 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth

  REVISED A RIGHT MEDIAL MCK UNI KNEE DUE TO LOOSENING OF BOTH THE FEMUR AND TIBIAL COMPONENTS.

  Patient problems: Inadequate Osseointegration; Joint Laxity

  MAUDE report 20458702 ↗
• InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2015: RIGHT MEDIAL MCK UNI KNEE EXCHANGE (B)(6) 2024: I&D ON A RIGHT KNEE THAT HAD AN MCK UNI ON BOTH THE MEDIAL AND LATERAL SIDES. (B)(6) 2024: REVISION OF TIBIAL INSERT, DUE TO SUSPECTED INFECTION. THIS REPORT IS DUE TO THE INFECTION REVISED ON (B)(6) 2024.

  Patient problems: Unspecified Infection

  MAUDE report 20449176 ↗
• InjuryAug 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT REPORTED THEY HAD A LEFT KNEE MAKO ROBOTIC ASSISTED PROCEDURE (KNEE TEP) AND NOTED HAVING FULL FLEXION AND EXTENSION, BUT REPORTED EXPERIENCING PAIN, SWELLING, HEAT, AND CLICKING.

  Patient problems: Arthralgia; Arthritis; Implant Pain

  MAUDE report 20061949 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISED A LEFT MEDIAL MCK UNI DUE TO DISEASE PROGRESSION (PATIENT DEVELOPED DISEASE IN THE OTHER COMPARTMENTS OF THE KNEE). NO MORE INFORMATION ARE AVAIALBLE.

  Patient problems: Arthralgia

  MAUDE report 19357634 ↗
• MalfunctionMay 8, 2024Device Damaged Prior to Use; Device Damaged Prior to Use

  AS REPORTED VIA MEDWATCH 5200630000-2023-8032: CEMENT VIAL PACKAGING APPEARS TO BE CLOUDY INCONSISTENT WITH THE PACKAGING FROM PRIOR CEMENT UNITS. NO PATIENT INVOLVEMENT HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19266148 ↗
• InjuryApr 29, 2024Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  DR. (B)(6) REVISED A LEFT MEDIAL UNI ORIGINALLY DONE ON (B)(6) 2023 DUE TO PERSISTENT PAIN. NO ALLEGATIONS WERE MADE AGAINST THE IMPLANTS. DR. HAS REVISED TO A PRIMARY TRIATHLON WITH UNIVERSAL BASEPLATE.

  Patient problems: Arthralgia; Implant Pain

  MAUDE report 19199819 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REVISED A LEFT MEDIAL UNI ORIGINALLY DONE ON (B)(6) 2023 DUE TO PERSISTENT PAIN. NO ALLEGATIONS WERE MADE AGAINST THE IMPLANTS. SHE REVISED TO A PRIMARY TRIATHLON WITH UNIVERSAL BASEPLATE.

  Patient problems: Pain

  MAUDE report 19130567 ↗
• InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO RANGE OF MOTION ISSUES. A CR FEMUR AND CS INSERT WERE REVISED TO A PS FEMUR WITH TS INSERT. THE REP CONFIRMED THAT THERE WERE NO ALLEGATIONS AGAINST THE REVISED INSERT, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Arthralgia; Loss of Range of Motion

  MAUDE report 18806451 ↗
• InjuryFeb 26, 2024Loss of Osseointegration; Loss of Osseointegration

  REVISED A RIGHT TRIATHLON FEMUR AND INSERT DUE TO FEMORAL LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18779364 ↗
• InjuryFeb 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INFECTION. ALL IMPLANTS (CR KNEE) WERE REMOVED AND A TS KNEE WAS IMPLANTED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. UPDATE 30/JANUARY/2024 (TO RELATED REPORT NUMBER 9615014-2023-00016): REP PROVIDED ADDITIONAL INFORMATION: PATIENT HAD ALLEGED AN ALLERGY TO THE CEMENT USED AFTER THE PRIMARY SURGERY ON (B)(6) 2023 AND REVISION ON (B)(6) 2023. ALLERGY TESTS WERE NEGATIVE. SURGEON REPORTED THAT THE PATIENT WAS PICKING AT THE WOUND WHICH LED TO INFLAMMATION AND DRAINAGE (REVISION REPORTED IN 9615014-2023-00016), AND LATER, INFECTION (REVISION REPORTED HERE IN 9615014-2024-00002).

  Patient problems: Arthralgia; Implant Pain; Unspecified Infection

  MAUDE report 18775631 ↗
• InjuryDec 18, 2023Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth

  DAUGHTER OF PATIENT REPORTED THAT WITHIN A YEAR OF PRIMARY RIGHT KNEE SURGERY, (B)(6) 2019, HER MOTHER EXPERIENCED IMPLANT "FAILURE" AND WITHIN TWO YEARS REQUIRED A REVISION, (B)(6), 2021. PATIENT EXPERIENCED A FEMUR FRACTURE DURING THE REVISION WHICH REQUIRED A "ROD" TO BE PLACED. PATIENT CURRENTLY EXPERIENCES RIGHT KNEE STIFFNESS AND SWELLING. PATIENT DID EXPERIENCE PAIN AT/AROUND HER THIRD POST OP VISIT WHICH SHE REPORTED TO HER SURGEON AT THE TIME. PATIENT CONFIRMED THAT SHE WAS ACTIVELY DOING PHYSICAL THERAPY AT THE TIME OF THE ONSET OF PAIN. UPDATE 11/14/2023: PER MEDICAL REVIEW ADDENDUM, THE SURGEON FOUND MALROTATION OF BOTH FEMUR AND TIBIA CONTRIBUTING TO THE PATIENT'S SYMPTOMS, AS WELL AS MOST LIKELY LOOSENING OF THE FEMORAL COMPONENT BASED UPON EASE OF REMOVAL. UPDATE: 11/27/2023: PER MED REVIEW, THE SURGEON STATES THERE WAS NOTICE OF PART OF THE CEMENT MANTLE BEING BROKEN OFF AT APPROXIMATELY 3 MONTHS AFTER THE SURGERY.

  Patient problems: Arthralgia; Implant Pain; Pain

  MAUDE report 18343827 ↗
• InjuryDec 12, 2023Fracture; Fracture

  DAUGHTER OF PATIENT REPORTED THAT WITHIN A YEAR OF PRIMARY RIGHT KNEE SURGERY, (B)(6) 2019, HER MOTHER EXPERIENCED IMPLANT "FAILURE" AND WITHIN TWO YEARS REQUIRED A REVISION, APRIL 7, 2021. PATIENT EXPERIENCED A FEMUR FRACTURE DURING THE REVISION WHICH REQUIRED A "ROD" TO BE PLACED. PATIENT CURRENTLY EXPERIENCES RIGHT KNEE STIFFNESS AND SWELLING. PATIENT DID EXPERIENCE PAIN AT/AROUND HER THIRD POST OP VISIT WHICH SHE REPORTED TO HER SURGEON AT THE TIME. PATIENT CONFIRMED THAT SHE WAS ACTIVELY DOING PHYSICAL THERAPY AT THE TIME OF THE ONSET OF PAIN. DAUGHTER IS INQUIRING IF IMPLANTS ARE SUBJECT TO A RECALL. UPDATE 11/14/2023: PER MEDICAL REVIEW ADDENDUM, THE SURGEON FOUND MALROTATION OF BOTH FEMUR AND TIBIA CONTRIBUTING TO THE PATIENT¿S SYMPTOMS, AS WELL AS MOST LIKELY LOOSENING OF THE FEMORAL COMPONENT BASED UPON EASE OF REMOVAL. UPDATE: 11/27/2023: PER MED REVIEW, THE SURGEON STATES THERE WAS NOTICE OF PART OF THE CEMENT MANTLE BEING BROKEN OFF AT APPROXIMATELY 3 MONTHS AFTER THE SURGERY

  Patient problems: Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 18312833 ↗
• InjuryDec 8, 2023Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INFLAMMATION AND DRAINAGE. IT DID NOT APPEAR TO BE INFECTED, BUT THE PATIENT REPORTED AN ALLERGY TO METHYL METHACRYLATE (THIS ALLERGY WAS NOT REPORTED TO THE SURGEON PRIOR TO IMPLANTATION) IN THE SIMPLEX HV CEMENT USED. AN I&D WAS PERFORMED AND POLY INSERT WAS REVISED.

  Patient problems: Arthralgia; Arthritis; Hypersensitivity/Allergic reaction; Implant Pain

  MAUDE report 18289492 ↗