Simplex 6191-1-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 07613327128444), received between Feb 7, 2017 and Sep 10, 2026 — classified as 3 deaths, 36 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (22 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 25 most recent of 76 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Loss of Osseointegration

  Patient problems: Inadequate Osseointegration

  MAUDE report 50722470 ↗
• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA MEDWATCH MW5172706: INCREASING SYMPTOMATIC INCISIONAL VENTRAL HERNIA.

  Patient problems: Hernia

  MAUDE report 22882028 ↗
• MalfunctionJun 26, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED VIA MEDSUN (B)(4): BONE CEMENT WAS OPENED TO THE FIELD. ALL PREP WAS COMPLETED CORRECTLY BY THE SURGICAL TECH. SURGEON NOTICED BONE CEMENT WAS HARDENING RAPIDLY. TYPICALLY, THE BONE CEMENT DOESN'T HARDEN AS FAST AS IT DID IN THIS CASE (SIMPLEX P HARDENED UNDER 9 MINUTES). DUE TO THE CEMENT HARDENING FASTER THAN USUAL, IT CAUSED THE CASE TO GO OVER TIME. SURGEON HAD TO REMOVE SOME OF THE CEMENT TO CORRECTLY PLACE THE IMPLANTS. SURGEON STATED, "THE CEMENT OPENED WAS A BAD BATCH."

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

  MAUDE report 22336091 ↗
• InjuryMay 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED VIA MEDWATCH MW5168818: STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE MILD SWELLING. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: NOT RELATED. PROCEDURE RELATED: POSSIBLY. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22.

  Patient problems: Swelling/ Edema

  MAUDE report 22042704 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA MEDWATCH MW5168819: CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE MILD SWELLING.

  Patient problems: Swelling/ Edema

  MAUDE report 22025438 ↗
• InjuryNov 12, 2024Noise, Audible; Noise, Audible

  AS REPORTED VIA MW5159967: CLICKING NOISE, HURTS WHEN LAYING DOWN. DEVICE LOCATION: LEFT. (NOTE: STRYKER CEMENT USED WITH COMPETITOR IMPLANTS).

  Patient problems: Pain

  MAUDE report 20667164 ↗
• DeathApr 3, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS PI IS FOR THE PATIENT DEATH. IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO FEMORAL PERIPROSTHETIC FRACTURE. THE PATIENT'S KNEE CONSTRUCT WAS REVISED TO A DISTAL FEMORAL REPLACEMENT. DURING REVISION, PATIENT'S BLOOD PRESSURE DROPPED. THE SURGERY WAS COMPLETED AND THE PATIENT CLOSED. PATIENT DIED POST-OPERATIVELY OUTSIDE OF THE O.R. (IT WAS NOT REPORTED TO THE REP WHERE THE PATIENT WAS AT TIME OF DEATH).

  Patient problems: Bone Cement Implantation Syndrome

  MAUDE report 19037631 ↗
• DeathApr 3, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS PI IS FOR THE PATIENT DEATH. IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO FEMORAL PERIPROSTHETIC FRACTURE. THE PATIENT'S KNEE CONSTRUCT WAS REVISED TO A DISTAL FEMORAL REPLACEMENT. DURING REVISION, PATIENT'S BLOOD PRESSURE DROPPED. THE SURGERY WAS COMPLETED AND THE PATIENT CLOSED. PATIENT DIED POST-OPERATIVELY OUTSIDE OF THE O.R. (IT WAS NOT REPORTED TO THE REP WHERE THE PATIENT WAS AT TIME OF DEATH).

  Patient problems: Bone Cement Implantation Syndrome

  MAUDE report 19037612 ↗
• InjuryFeb 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA MEDWATCH MW5150153: CLINICAL ADVERSE EVENT RECEIVED FOR LEFT LOWER EXTREMITY SWELLING. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE.

  Patient problems: Swelling/ Edema

  MAUDE report 18785437 ↗
• InjurySep 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA MEDWATCH MW5120391: "CLINICAL ADVERSE EVENT RECEIVED FOR INTERMITTENT LOCKING OF LEFT KNEE." REPORT INDICATES KNEE WAS REVISED.

  Patient problems: Loss of Range of Motion

  MAUDE report 17786717 ↗
• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WEAKNESS IN RIGHT KNEE. KNEE BUCKLES AND CANNOT SUPPORT WEIGHT, CAUSING FALLS. L KNEE REPLACED IN (B)(6) 2015. NO ISSUES WITH THIS KNEE. RIGHT KNEE REPLACED IN (B)(6) 2015, AND IS CAUSING ISSUES. HAVE THERE BEEN ANY RECALLS OR ISSUES WITH THIS PRODUCT AS THE PLASTIC PIECE IN BETWEEN HAS WORN DOWN TO ALMOST NOTHING.

  Patient problems: Fall

  MAUDE report 14726570 ↗
• InjuryMay 30, 2022Loss of Osseointegration; Loss of Osseointegration

  PATIENT HAD A REVISION FOR LOOSENING OF A COMPETITOR FEMORAL COMPONENT WHICH WAS CEMENTED WITH STRYKER CEMENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14539718 ↗
• InjuryMay 30, 2022Loss of Osseointegration; Loss of Osseointegration

  PATIENT HAD A REVISION FOR LOOSENING OF A COMPETITOR FEMORAL COMPONENT, WHICH WAS CEMENTED WITH STRYKER CEMENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14539716 ↗
• InjuryMay 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A REVISION OF A ¿GROSSLY LOOSE¿ COMPETITOR BASEPLATE CEMENTED WITH STRYKER CEMENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14495707 ↗
• InjuryMay 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A REVISION OF A ¿GROSSLY LOOSE¿ COMPETITOR'S BASEPLATE CEMENTED WITH STRYKER CEMENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14495691 ↗
• InjuryMay 25, 2022Osseointegration Problem; Osseointegration Problem

  PATIENT HAD A REVISION FOR ASEPTIC LOOSENING OF A S&N BASEPLATE CEMENTED WITH STRYKER CEMENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14494457 ↗
• InjuryMay 25, 2022Osseointegration Problem; Osseointegration Problem

  PATIENT HAD A REVISION FOR ASEPTIC LOOSENING OF A S&N BASEPLATE CEMENTED WITH STRYKER CEMENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14494443 ↗
• InjuryJan 16, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO FEMORAL LOOSENING. INTRA-OPERATIVELY, IT WAS NOTED THAT THE CEMENT (2 DOSES OF THE SAME LOT WERE MIXED TOGETHER) WAS BONDED TO THE IMPLANT BUT NOT THE PATIENT'S BONE. HOWEVER, THE SAME CEMENT WAS USED FOR THE TIBIA AND WAS WELL-FIXED TO BOTH IMPLANT AND BONE. THE FEMORAL COMPONENT AND INSERT WERE REVISED TO A TS FEMUR WITH STEM AND NEW INSERT. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED INSERT, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 13262662 ↗
• InjuryJan 16, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO FEMORAL LOOSENING. INTRA-OPERATIVELY, IT WAS NOTED THAT THE CEMENT (2 DOSES OF THE SAME LOT WERE MIXED TOGETHER) WAS BONDED TO THE IMPLANT BUT NOT THE PATIENT'S BONE. HOWEVER, THE SAME CEMENT WAS USED FOR THE TIBIA AND WAS WELL-FIXED TO BOTH IMPLANT AND BONE. THE FEMORAL COMPONENT AND INSERT WERE REVISED TO A TS FEMUR WITH STEM AND NEW INSERT. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED INSERT, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 13262661 ↗
• InjuryJul 6, 2021Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED BY REP: "SHE PRESENTED IN 2021 WITH GROSS INSTABILITY AND A COLLAPSED MEDIAL TIBIA. AT TIME OF SURGERY IT WAS NOTED THAT THE CEMENT INTERFACE WAS LOOSE. CULTURES AND GRAM STAINS WERE NEGATIVE RULING OUT INFECTION. WE REMOVED ALL BUT PATELLA, REVISED TO TRIATHLON TOTAL STABILIZER SUCCESSFULLY." PRIMARY AND REVISION USAGE WERE PROVIDED. SPOKE TO THE REP, WHO CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12123196 ↗
• InjuryNov 16, 2020Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO PAINFUL AND UNSTABLE LEFT TOTAL KNEE ARTHROPLASTY. *UPDATE ON 11-MARCH-2022 PER MEDICAL REVIEW: "[...] JUNE 28, 2017: THERE IS IN OPERATION REPORT FROM DR. THE PRE-AND POSTOP DIAGNOSIS WAS PAINFUL AND UNSTABLE LEFT TOTAL KNEE ARTHROPLASTY. THE OPERATION PERFORMED WAS A REVISION LEFT TOTAL KNEE ARTHROPLASTY. THE IMPLANTS UTILIZED WERE A STRYKER TRIATHLON X3 19 MM POLYETHYLENE INSERT CS SIZE #6. OPERATIVE FINDINGS INCLUDED WELL FIXED IMPLANTS, NO PATELLA WEAR, MILD POSTERIOR MEDIAL TIBIAL INSERT WEAR, A FLEXION GAP THAT WAS EQUAL IN SIZE TO THE EXTENSION GAP, COMPETENT POSTERIOR CRUCIATE LIGAMENT, FEMORAL AXIAL ROTATION SLIGHTLY EXTERNAL TO THE TIBIA WITH THE TIBIAL ROTATION AT THE JUNCTION OF THE MEDIAL AND MIDDLE THIRD OF THE TIBIAL TUBERCLE. THERE WAS CLEAR YELLOW FLUID PRESENT BUT NO EVIDENCE OF INFECTION. A 19 MM CS INSERT PROVIDED SATISFACTORY STABILITY ACCORDING TO THE SURGEON. [...]"

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain

  MAUDE report 10842935 ↗
• InjuryOct 9, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT STATED HE HAD A LEFT TKA DONE ON (B)(6) 2018, HE WAS IMPLANTED WITH STRYKER CEMENT AND COMPETITOR IMPLANTS. PATIENT HAD PHYSICAL THERAPY AFTER SURGERY. ON (B)(6) OF 2018 PATIENT STARTED TO EXPERIENCE EXCRUCIATING PAIN WALKING UP AND DOWN THE STAIRS. ON (B)(6) 2019 HE SAW DR. (B)(6) AND WAS RECOMMEND A BONE SCAN, BASED ON THE RESULTS HE WAS TOLD HE NEEDED TO BE REVISED AS THE CEMENT USED WAS DEBONDED AND BREAKING UP. PATIENT REACHED OUT TO HIS PRIMARY SURGEON AND WAS REVISED. PATIENT HAD PHYSICAL THERAPY. IN MID (B)(6) 2019 PATIENT STARTED TO EXPERIENCE EXCRUCIATING PAIN. HE WENT FOR AN X-RAY AND A COUPLE OF DAYS LATER HE HAD AN MRI AND WAS TOLD HE HAD A FRACTURED KNEE CAP DUE TO THE CEMENT BREAKING UP AND DEBONDING. TWO MONTHS AGO PATIENT STATED HE WAS WALKING DOWN THE STAIRS WHEN FELT A POP, COULD NOT LIFT HIS LEFT HEEL UP AND EXPERIENCED EXCRUCIATING PAIN. HE HAD AN EMERGENCY MRI AND MET WITH HIS SURGEON AND WAS TOLD HE HAD SCAR TISSUE THAT HAD DEVELOPED. PATIENT IS STILL EXPERIENCING EXCRUCIATING PAIN. PATIENT IS SEEKING COMPENSATION. THIS PI IS FOR REVISION OF THE PRIMARY.

  Patient problems: Pain

  MAUDE report 10654514 ↗
• InjuryOct 9, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT STATED HE HAD A LEFT TKA DONE ON (B)(6) 2018, HE WAS IMPLANTED WITH STRYKER CEMENT AND COMPETITOR IMPLANTS. PATIENT HAD PHYSICAL THERAPY AFTER SURGERY. ON (B)(6) 2018 PATIENT STARTED TO EXPERIENCE EXCRUCIATING PAIN WALKING UP AND DOWN THE STAIRS. ON (B)(6) 2019 HE SAW DR. (B)(6) AND WAS RECOMMEND A BONE SCAN, BASED ON THE RESULTS HE WAS TOLD HE NEEDED TO BE REVISED AS THE CEMENT USED WAS DEBONDED AND BREAKING UP. PATIENT REACHED OUT TO HIS PRIMARY SURGEON AND WAS REVISED. PATIENT HAD PHYSICAL THERAPY. IN (B)(6) 2019 PATIENT STARTED TO EXPERIENCE EXCRUCIATING PAIN. HE WENT FOR AN X-RAY AND A COUPLE OF DAYS LATER HE HAD AN MRI AND WAS TOLD HE HAD A FRACTURED KNEE CAP DUE TO THE CEMENT BREAKING UP AND DEBONDING. TWO MONTHS AGO PATIENT STATED HE WAS WALKING DOWN THE STAIRS WHEN FELT A POP, COULD NOT LIFT HIS LEFT HEEL UP AND EXPERIENCED EXCRUCIATING PAIN. HE HAD AN EMERGENCY MRI AND MET WITH HIS SURGEON AND WAS TOLD HE HAD SCAR TISSUE THAT HAD DEVELOPED. PATIENT IS STILL EXPERIENCING EXCRUCIATING PAIN. PATIENT IS SEEKING COMPENSATION. THIS PI IS FOR REVISION OF THE PRIMARY.

  Patient problems: Pain

  MAUDE report 10654511 ↗
• InjuryOct 9, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT STATED HE HAD A LEFT TKA DONE ON (B)(6) 2018, HE WAS IMPLANTED WITH STRYKER CEMENT AND COMPETITOR IMPLANTS. PATIENT HAD PHYSICAL THERAPY AFTER SURGERY. ON OCT/NOV OF 2018 PATIENT STARTED TO EXPERIENCE EXCRUCIATING PAIN WALKING UP AND DOWN THE STAIRS. ON (B)(6) OF 2019 HE SAW DR. (B)(6) AND WAS RECOMMEND A BONE SCAN, BASED ON THE RESULTS HE WAS TOLD HE NEEDED TO BE REVISED AS THE CEMENT USED WAS DE-BONDING AND BREAKING UP. PATIENT REACHED OUT TO HIS PRIMARY SURGEON AND WAS REVISED. PATIENT HAD PHYSICAL THERAPY. IN MID (B)(6) 2019 PATIENT STARTED TO EXPERIENCE EXCRUCIATING PAIN. HE WENT FOR AN X-RAY AND A COUPLE OF DAYS LATER HE HAD AN MRI AND WAS TOLD HE HAD A FRACTURED KNEE CAP DUE TO THE CEMENT BREAKING UP AND DE-BONDING. TWO MONTHS AGO PATIENT STATED HE WAS WALKING DOWN THE STAIRS WHEN FELT A POP, COULD NOT LIFT HIS LEFT HEEL UP AND EXPERIENCED EXCRUCIATING PAIN. HE HAD AN EMERGENCY MRI AND MET WITH HIS SURGEON AND WAS TOLD HE HAD SCAR TISSUE THAT HAD DEVELOPED. PATIENT IS STILL EXPERIENCING EXCRUCIATING PAIN. PATIENT IS SEEKING COMPENSATION. THIS PI IS FOR REVISION OF THE PRIMARY.

  Patient problems: Pain

  MAUDE report 10654510 ↗
• InjurySep 22, 2020Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  SIMPLEX P SET HARD IN 4-5 MINUTES. UPDATE: THE NATURE OF THE PROCEDURE BEING PERFORMED WAS A TOTAL HIP. THE PATIENT'S FEMUR FRACTURED, REQUIRING CABLES. SURGICAL DELAY OF UNKNOWN DURATION.

  Patient problems: Bone Fracture(s)

  MAUDE report 10567214 ↗