Simplex 6197-9-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 07613327128420), received between Jan 26, 2017 and Jan 8, 2026 — classified as 2 deaths, 32 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 reports).

2 other recalls cover devices cleared under the same FDA submission (K014199); they may or may not involve this specific model.

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 57 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2026Loss of Osseointegration

  UPDATE: LEFT SIDE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24002625 ↗
• InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR R ANTERIOR KNEE PAIN. DEVICE RELATEDNESS: POSSIBLY RELATED. PROCEDURE RELATEDNESS: DEFINITELY RELATED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

  Patient problems: Pain

  MAUDE report 21112276 ↗
• InjuryDec 16, 2024Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO LOOSENING OF THE TIBIA AND FEMUR. INTRA-OPERATIVELY, IT WAS ALSO OBSERVE THAT BOTH STEMS (TIBIAL AND FEMORAL) BROKE OFF APPROXIMATELY HALFWAY UP THEIR THREADING. THE PATIENT'S TS KNEE WAS CONVERTED TO A COMPETITOR REVISION KNEE (PATELLAR COMPONENT WAS RETAINED). REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20937363 ↗
• InjuryDec 16, 2024Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO LOOSENING OF THE TIBIA AND FEMUR. INTRA-OPERATIVELY, IT WAS ALSO OBSERVE THAT BOTH STEMS (TIBIAL AND FEMORAL) BROKE OFF APPROXIMATELY HALFWAY UP THEIR THREADING. THE PATIENT'S TS KNEE WAS CONVERTED TO A COMPETITOR REVISION KNEE (PATELLAR COMPONENT WAS RETAINED). REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20937359 ↗
• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA MW5161062: CLINICAL ADVERSE EVENTS RECEIVED FOR ABDOMINAL PAIN DEVICE AND PROCEDURE (RELATEDNESS).

  Patient problems: Pain

  MAUDE report 20818400 ↗
• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA MW5159942 AND MW5159943: CLINICAL ADVERSE EVENT RECEIVED FOR PAIN IN BOTH KNEES. DEVICE RELATED: INFORMATION NOT PROVIDED. PROCEDURE RELATED: INFORMATION NOT PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/ IMPACT: NO INTERVENTION/ TREATMENT AT THIS TIME.

  Patient problems: Pain

  MAUDE report 20682775 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA MW5159493: CLINICAL ADVERSE EVENT RECEIVED FOR STIFFNESS WITH <90 DEGREES FLEXION.

  Patient problems: Loss of Range of Motion

  MAUDE report 20569720 ↗
• InjurySep 16, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED VIA PHONE "I'M HAVING PROBLEMS WITH MY KNEE AND WANT TO KNOW IF THERE HAS BEEN A RECALL ON THE IMPLANTS."

  Patient problems: Insufficient Information

  MAUDE report 20233745 ↗
• DeathSep 3, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  BHA WAS PERFORMED FOR RIGHT FEMORAL NECK FRACTURE. TWO MINUTES AFTER FILLING THE INTRATHECAL CAVITY WITH CEMENT AND INSERTING THE STEM, THE OXYGEN SATURATION LEVEL BEGAN TO GRADUALLY DECREASE, FOLLOWED BY A DROP IN BLOOD PRESSURE AND THE PATIENT WENT INTO CARDIAC ARREST. THE PATIENT WAS CONFIRMED DEAD ON THE SAME DAY.

  Patient problems: Bone Cement Implantation Syndrome; Cardiac Arrest; Low Blood Pressure/ Hypotension

  MAUDE report 20125531 ↗
• DeathSep 3, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  BHA WAS PERFORMED FOR RIGHT FEMORAL NECK FRACTURE. TWO MINUTES AFTER FILLING THE INTRATHECAL CAVITY WITH CEMENT AND INSERTING THE STEM, THE OXYGEN SATURATION LEVEL BEGAN TO GRADUALLY DECREASE, FOLLOWED BY A DROP IN BLOOD PRESSURE AND THE PATIENT WENT INTO CARDIAC ARREST. THE PATIENT WAS CONFIRMED DEAD ON THE SAME DAY.

  Patient problems: Bone Cement Implantation Syndrome; Cardiac Arrest; Low Blood Pressure/ Hypotension

  MAUDE report 20125415 ↗
• InjurySep 27, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT WITH PATHOLOGICAL FRACTURE OF RIGHT FEMUR DUE TO PROSTATE CANCER METASTASIS UNDERWENT GMRS FEMORAL ARTHROPLASTY AND BIPOLAR HIP ARTHROPLASTY ON (B)(6) 2023. AFTER CEMENT WAS INJECTED INTO THE FEMUR AND THE GMRS STEM WAS INSERTED, THE PATIENT SUDDENLY SUFFERED CARDIAC ARREST DURING WAITING POLYMERISATION. WHILE CPR WAS PERFORMED AND ROSC WAS CONFIRMED 7 MINUTES AFTER CARDIAC ARREST, THE SURGERY WAS DISCONTINUED.

  Patient problems: Bone Cement Implantation Syndrome; Cardiac Arrest

  MAUDE report 17824142 ↗
• InjurySep 24, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT WITH PATHOLOGICAL FRACTURE OF RIGHT FEMUR DUE TO PROSTATE CANCER METASTASIS UNDERWENT GMRS FEMORAL ARTHROPLASTY AND BIPOLAR HIP ARTHROPLASTY ON (B)(6) 2023. AFTER CEMENT WAS INJECTED INTO THE FEMUR AND THE GMRS STEM WAS INSERTED, THE PATIENT SUDDENLY SUFFERED CARDIAC ARREST DURING WAITING POLYMERISATION. WHILE CPR WAS PERFORMED AND ROSC WAS CONFIRMED 7 MINUTES AFTER CARDIAC ARREST, THE SURGERY WAS DISCONTINUED.

  Patient problems: Bone Cement Implantation Syndrome; Cardiac Arrest

  MAUDE report 17805302 ↗
• InjuryFeb 23, 2023Loss of Osseointegration; Patient Device Interaction Problem; Loss of Osseointegration; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO PAIN, STIFFNESS, RESORPTION AND LOOSENING. SURGEON SUSPECTS THE CAUSE AS: "I THINK HER BODY IS REACTING TO AND REJECTING THE BONE CEMENT. AN ALLERGY HAS TO BE CONSIDERED." CEMENT WAS REMOVED AND THE STEM AND HEAD REVISED. THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration; Pain; Reaction to Medicinal Component of Device

  MAUDE report 16431494 ↗
• InjuryFeb 23, 2023Loss of Osseointegration; Patient Device Interaction Problem; Loss of Osseointegration; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO PAIN, STIFFNESS, RESORPTION AND LOOSENING. SURGEON SUSPECTS THE CAUSE AS: "I THINK HER BODY IS REACTING TO AND REJECTING THE BONE CEMENT. AN ALLERGY HAS TO BE CONSIDERED." CEMENT WAS REMOVED AND THE STEM AND HEAD REVISED. THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration; Pain; Reaction to Medicinal Component of Device

  MAUDE report 16425668 ↗
• InjuryJan 31, 2023Loss of Osseointegration; Patient Device Interaction Problem; Loss of Osseointegration; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. OFFICE VISIT NOTES REPORT PATIENT COMPLAINT OF PAIN WITH 'PROFOUND BONE LOSS AROUND THE FEMORAL CEMENT MANTLE.' SURGEON REPORTED SUSPICION OF PATIENT REACTION TO CEMENT (IT IS UNCLEAR IF THIS IS ATTRIBUTED TO THE SIMPLEX CEMENT OR THE CEMENT BONE PLUG, BUT LESIONS OF THE FEMUR WERE NOTED TO BE HIGHER UP/ FURTHER AWAY FROM THE BONE PLUG). THE CEMENT, PLUG, STEM, HEAD AND LINER WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD AND LINER.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration; Pain

  MAUDE report 16271179 ↗
• InjuryJan 5, 2023Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  BLOOD PRESSURE DECREASED. CARDIAC ARREST SHOULD NOT HAVE OCCURRED.

  Patient problems: Cardiac Arrest

  MAUDE report 16100770 ↗
• InjuryJan 5, 2023Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  BLOOD PRESSURE DECREASED. CARDIAC ARREST SHOULD NOT HAVE OCCURRED.

  Patient problems: Cardiac Arrest

  MAUDE report 16100472 ↗
• MalfunctionJul 25, 2022Fracture; Fracture

  THE FOLLOWING WAS REPORTED: "THE AMPOULE BOTTLE BREAKS EVERY TIME I OPEN THE MONOMER. IT'S DANGEROUS AND I WANT THE PACKAGE TO BE CHANGED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15093308 ↗
• MalfunctionJul 25, 2022Fracture; Fracture

  THE FOLLOWING WAS REPORTED: "THE AMPOULE BOTTLE BREAKS EVERY TIME I OPEN THE MONOMER. IT'S DANGEROUS AND I WANT THE PACKAGE TO BE CHANGED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15093302 ↗
• MalfunctionJun 27, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  PRIMARY MAKO LEFT TKA. IT WAS REPORTED THAT THE 2 DOSES OF CEMENT WERE BECOMING HARDENED AT 9.5-10 MINUTES (5 MINUTES SOONER THAN EXPECTED). IN ORDER TO NOT WASTE THE CEMENT, THE PACE OF SURGERY WAS INCREASED IN ORDER TO IMPLANT THE ORIGINALLY PLANNED IMPLANTS. NO SURGICAL DELAY. ADDITIONAL INFORMATION PROVIDED: ALL CEMENT AND MONOMER USED. NOTHING ADDED. NO WATER, SALINE, BLOOD, FAT, ETC PRESENT. STORAGE TEMPERATURE IN THE LOW 70'S F (DETAILS TO BE PROVIDED INCLUDING HUMIDITY) - BOTH FOR THE CEMENT AND THE MIXING APPARATUS. NO REFRIGERATOR STORAGE. CEMENT WAS IN STORAGE UNDER THE OR FOR APPROXIMATELY 2 WEEKS (SEPARATE FROM STERILE STORAGE, BUT SAME CONDITIONS). CEMENT WAS IN THE O.R. APPROXIMATELY 2 DAYS. OR TEMPERATURE 63-64° F. WALL TIMER WAS USED TO RECORD SETTING TIME. THE HOSPITAL HAD 2 INCIDENTS WITH ITS AIR CONDITIONING. IT WENT DOWN APPROXIMATELY 2 WEEKS PRIOR ((B)(6) 2022) FOR AN UNKNOWN AMOUNT OF TIME AND AGAIN ON (B)(6) 2022 FOR AN UNKNOWN AMOUNT OF TIME. REP REPORTED INFORMATION ON THE STORAGE CONDITIONS (TEMP AND HUMIDITY) CAN BE OBTAINED BUT THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14826749 ↗
• MalfunctionJun 27, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  PRIMARY MAKO LEFT TKA. IT WAS REPORTED THAT THE 2 DOSES OF CEMENT WERE BECOMING HARDENED AT 9.5-10 MINUTES (5 MINUTES SOONER THAN EXPECTED). IN ORDER TO NOT WASTE THE CEMENT, THE PACE OF SURGERY WAS INCREASED IN ORDER TO IMPLANT THE ORIGINALLY PLANNED IMPLANTS. NO SURGICAL DELAY. ADDITIONAL INFORMATION PROVIDED: ALL CEMENT AND MONOMER USED. NOTHING ADDED. NO WATER, SALINE, BLOOD, FAT, ETC PRESENT. STORAGE TEMPERATURE IN THE LOW 70'S F (DETAILS TO BE PROVIDED INCLUDING HUMIDITY) - BOTH FOR THE CEMENT AND THE MIXING APPARATUS. NO REFRIGERATOR STORAGE. CEMENT WAS IN STORAGE UNDER THE OR FOR APPROXIMATELY 2 WEEKS (SEPARATE FROM STERILE STORAGE, BUT SAME CONDITIONS). CEMENT WAS IN THE O.R. APPROXIMATELY 2 DAYS. OR TEMPERATURE 63-64° F. WALL TIMER WAS USED TO RECORD SETTING TIME. THE HOSPITAL HAD 2 INCIDENTS WITH ITS AIR CONDITIONING. IT WENT DOWN APPROXIMATELY 2 WEEKS PRIOR (24-MAY-22) FOR AN UNKNOWN AMOUNT OF TIME AND AGAIN ON 28-MAY-22 FOR AN UNKNOWN AMOUNT OF TIME. REP REPORTED INFORMATION ON THE STORAGE CONDITIONS (TEMP AND HUMIDITY) CAN BE OBTAINED BUT THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14826748 ↗
• MalfunctionJun 24, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  PRIMARY MAKO LEFT TKA. IT WAS REPORTED THAT THE DOSE OF CEMENT HARDENED AT 10 MINUTES (5 MINUTES SOONER THAN EXPECTED). BECAUSE THE IMPLANTS COULD NOT BE IMPLANTED, THE CEMENT WAS REMOVED (INCLUDING CHISELLING IT OUT) AND A SECOND BATCH MIXED. THE SECOND BATCH HARDENED AT APPROXIMATELY 8.5 MINUTES, BUT AS THE ONLY IMPLANTS LEFT TO ADDRESS WERE THE FEMUR AND PATELLA, THE IMPLANTS WERE ABLE TO BE IMPLANTED. SURGICAL DELAY 15-20 MINUTES. ADDITIONAL INFORMATION PROVIDED: ALL CEMENT AND MONOMER USED. NOTHING ADDED. NO WATER, SALINE, BLOOD, FAT, ETC PRESENT. STORAGE TEMPERATURE IN THE LOW 70'S F (DETAILS TO BE PROVIDED INCLUDING HUMIDITY) - BOTH FOR THE CEMENT AND THE MIXING APPARATUS. NO REFRIGERATOR STORAGE. CEMENT WAS IN STORAGE UNDER THE OR FOR APPROXIMATELY 2 WEEKS (SEPARATE FROM STERILE STORAGE, BUT SAME CONDITIONS). CEMENT WAS IN THE O.R. APPROXIMATELY 2 DAYS. OR TEMPERATURE 63-64° F. WALL TIMER WAS USED TO RECORD SETTING TIME. THE HOSPITAL HAD 2 INCIDENTS WITH ITS AIR CONDITIONING. IT WENT DOWN APPROXIMATELY 2 WEEKS PRIOR (B)(6) 2022 FOR AN UNKNOWN AMOUNT OF TIME AND AGAIN ON (B)(6) 2022 FOR AN UNKNOWN AMOUNT OF TIME. REP REPORTED INFORMATION ON THE STORAGE CONDITIONS (TEMP AND H

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14797722 ↗
• MalfunctionJun 24, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  PRIMARY MAKO LEFT TKA. IT WAS REPORTED THAT THE DOSE OF CEMENT HARDENED AT 10 MINUTES (5 MINUTES SOONER THAN EXPECTED). BECAUSE THE IMPLANTS COULD NOT BE IMPLANTED, THE CEMENT WAS REMOVED (INCLUDING CHISELLING IT OUT) AND A SECOND BATCH MIXED. THE SECOND BATCH HARDENED AT APPROXIMATELY 8.5 MINUTES, BUT AS THE ONLY IMPLANTS LEFT TO ADDRESS WERE THE FEMUR AND PATELLA, THE IMPLANTS WERE ABLE TO BE IMPLANTED. SURGICAL DELAY 15-20 MINUTES. ADDITIONAL INFORMATION PROVIDED: ALL CEMENT AND MONOMER USED. NOTHING ADDED. NO WATER, SALINE, BLOOD, FAT, ETC PRESENT. STORAGE TEMPERATURE IN THE LOW 70'S F (DETAILS TO BE PROVIDED INCLUDING HUMIDITY) - BOTH FOR THE CEMENT AND THE MIXING APPARATUS. NO REFRIGERATOR STORAGE. CEMENT WAS IN STORAGE UNDER THE OR FOR APPROXIMATELY 2 WEEKS (SEPARATE FROM STERILE STORAGE, BUT SAME CONDITIONS). CEMENT WAS IN THE O.R. APPROXIMATELY 2 DAYS. OR TEMPERATURE 63-64° F. WALL TIMER WAS USED TO RECORD SETTING TIME. THE HOSPITAL HAD 2 INCIDENTS WITH ITS AIR CONDITIONING. IT WENT DOWN APPROXIMATELY 2 WEEKS PRIOR (24-MAY-22) FOR AN UNKNOWN AMOUNT OF TIME AND AGAIN ON 28-MAY-22 FOR AN UNKNOWN AMOUNT OF TIME. REP REPORTED INFORMATION ON THE STORAGE CONDITIONS (TEMP AND HUM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14797537 ↗
• InjuryJun 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "ABOUT 3-4 WEEKS POST REIMPLANTATION SURGERY, THE SUBJECT CONTINUED TO HAVE DRAINAGE FROM HER LEFT KNEE. REPEAT ASPIRATION WAS STILL POSITIVE FOR INFECTION. AT THIS TIME THE INFECTION HAS BECOME CHRONIC AND AND THE PATIENT WAS INDICATED FOR AN EXPLANT AND PLACEMENT OF A STATIC ANTIBIOTIC SPACER. FINDINGS: GROSS INTRAOPERATIVE PURULENCE WITH INFLAMED SYNOVIUM WELL FIXED FEMORAL AND TIBIAL AND PATELLAR COMPONENTS." UPDATE 02 JUNE 2022. BASED ON THE MEDICAL REVIEW " WHILE EXTRACTING CEMENT FROM THE FEMORAL CANAL THERE WAS A ¿SMALL FRACTURE" OF THE ANTERIOR CORTEX WHICH WAS TREATED WITH A SINGLE CABLE". THE PROCEDURE WAS COMPLETED INSERTING A STATIC SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 14797102 ↗
• InjuryMay 14, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THA WITH STRYKER DEVICES WERE PERFORMED AFTER REMOVAL OF THE GAMMA TYPE MADE BY MDM (B)(4). AFTER INSERTION OF THE EXETER, THE PATIENT'S BLOOD PRESSURE AND SATURATION DID NOT RISE, AND PULMONARY EMBOLUS WAS SUSPECTED. THE SURGERY WAS NOT INTERRUPTED AND WAS CONTINUED TO THE END. THE PATIENT'S CONDITION IS UNKNOWN.

  Patient problems: Embolism/Embolus; Pulmonary Edema

  MAUDE report 14403127 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K014199. One submission often covers many models, so check the product and lot details in each record.

• Z-0737-2023 · Nov 7, 2022 · Open, Classified
  Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001
• Z-0467-2007 · Nov 7, 2006 · Terminated
  Simplex P with Tobramycin. Antibiotic PMMA Bone Cement.