Simplex HV with Gentamicin 6195-1-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 04260056885761), received between Aug 19, 2016 and Jun 26, 2026 — classified as 62 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (17 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Oct 21, 2022Class IIOpen, Classified

   Simplex HV With Gentamicin CE, 10 PACKS (P/N 6193-1-010) were distributed to customers who had ordered Simplex HV With Gentamicin in US, 10 PACKS (P/N 6195-1-010)

   Z-0240-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL KNEE REPLACEMENT ON (B)(6) 2024. IN LATE (B)(6), THE PATIENT ALLEGEDLY DEVELOPED INCREASING PAIN AND FUNCTIONAL IMPAIRMENT. THE PATIENT WAS REVISED ON (B)(6) 2025 DUE TO THE ALLEGED "FAILURE OF THE POLYETHYLENE LINER, WHICH PERMITTED ABNORMAL MOVEMENT AND MISALIGNMENT OF THE FEMORAL AND TIBIAL COMPONENTS".

  Patient problems: Arthralgia; Loss of Range of Motion

  MAUDE report 25634353 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. AN I&D WITH WASHOUT AND POLY SWAP OF A 4X9 CS INSERT WAS PERFORMED.

  Patient problems: Implant Pain; Unspecified Infection

  MAUDE report 23741362 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED; HE HAD A PARTIAL KNEE REPLACEMENT WITH STRYKER ORTHOPEDICS KNEE AND HAVING PROBLEMS WITH IT. SWELLING WITH FLUIDS AND PAIN. FLUIDS WERE DRAINED BUT RETURNED. PATIENT HAS RECEIVED SHOTS OF CORTISONE.

  Patient problems: Arthralgia; Arthritis; Implant Pain; Joint effusion

  MAUDE report 23356123 ↗
• InjuryMay 14, 2025Expiration Date Error; Expiration Date Error

  A SALES GENERAL MANAGER REPORTED THAT, ACCORDING TO A SALES REP, A SURGEON HAD INADVERTENTLY USED SIMPLEX HV WITH GENTAMICIN DURING A TOTAL KNEE REPLACEMENT THAT WAS EXPIRED SINCE TWO YEARS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22017970 ↗
• InjuryJun 26, 2024Adverse 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 INFORMATION PROVIDED BY THE US DISTRIBUTION PARTNER: "MY KNEE NEVER FULLY WORKED AFTER THE SURGERY AND THE IMPLANT BECAME LOOSE, MY KNEE WOULD BEND ALL THE WAY BACKWARDS , I'VE FALLEN A FEW TIMES AND SO MUCH PAIN. I ALSO HAVE TO GET KNEE REPLACEMENT TO REPLACE THE IMPLANT AND CURRENTLY WEARING A BRACE. DID THERAPY AT HOME AND WITH THERAPIST. SCHEDULED SURGERY IN 2024 TO REPLACE THE ORIGINAL IMPLANT." NO INFORMATION REGARDING THE REVISION SURGERY HAS BEEN PROVIDED.

  Patient problems: Arthralgia; Implant Pain; Joint Laxity

  MAUDE report 19612001 ↗
• InjuryJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY." RIGHT KNEE. A 3X13 TS INSERT WAS EXCHANGED FOR ANOTHER.

  Patient problems: Unspecified Infection

  MAUDE report 19535036 ↗
• InjuryJan 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH DISTRIBUTORS FACEBOOK PAGE: "MY MAKO KNEE LASTED 8 WEEKS ! I HAD A REVISION A FEW YEARS LATER!" UPDATE PER CONVERSATION WITH PATIENT: "PATIENT HAD A PRIMARY RIGHT MAKO PARTIAL KNEE AND WAS REVISED TO CONVERT TO A FULL KNEE. PATIENT REPORTED THAT SURGEON CHOSE TO CONVERT TO A FULL KNEE AS THE "OUTER PORTION OF THE HIS NATIVE KNEE BECAME BONE ON BONE". UPDATE: PER CLINICIAN REVIEW OF PROVIDED MEDICAL RECORDS: X-RAYS IN 2016 AND 2017 SHOWED ADVANCED OA OF THE LATERAL COMPARTMENT AND WEAR OF THE POLYETHYLENE WITH SOME LIKELY SUBSIDENCE.

  Patient problems: Arthralgia; Implant Pain

  MAUDE report 18578203 ↗
• InjuryMay 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED AFTER PATIENT COMPLAINT OF PAIN FOLLOWING 2 FALLS. PRIOR TO THE FALLS THE KNEE WAS GREAT. PRE-OPERATIVELY, SURGEON REPORTED TIBIAL FRACTURE AND BASEPLATE SUBSIDENCE. THE BASEPLATE, INSERT, AND FEMORAL COMPONENT WERE REVISED. THE SALES REP CONFIRMED FEMUR WAS REVISED TO CONVERT TO A PS KNEE, AND THAT THERE WERE NO ALLEGATIONS AGAINST THE REVISED INSERT. THE PATELLAR COMPONENT WAS RETAINED. THE REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Arthralgia; Implant Pain

  MAUDE report 16944038 ↗
• InjuryDec 27, 2022Adverse 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 SWELLING, CLANKING, AND JOINT LAXITY. A CR CEMENTED FEMUR AND CS INSERT WERE REVISED TO PS IMPLANTS. THE REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Arthralgia; Implant Pain; Joint Laxity

  MAUDE report 16049971 ↗
• InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  A PATIENT REPORTED PRIMARY RIGHT KNEE IMPLANT ON (B)(6) 2021 AND REPORTED ONGOING PAIN AND INSTABILITY.

  Patient problems: Arthralgia; Implant Pain; Joint Laxity

  MAUDE report 15993941 ↗
• InjuryOct 29, 2022Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED VIA MW5112078: THIS PATIENT HAD A TOTAL KNEE REPLACEMENT PERFORMED ON THE DATE INDICATED. THE KNEE FAILED MUCH EARLIER THAN EXPECTED. WORK UP WAS NEGATIVE FOR INFECTION. THE RECORDS INDICATE THE ORIGINAL SURGERY WAS DONE USING STRYKER HIGH VISCOSITY BONE CEMENT FOR THE KNEE REPLACEMENT SURGERY. THE PATIENT HAD TO HAVE REVISION SURGERY AS INDICATED. THE FINDINGS AT THE TIME OF SURGERY WERE CLASSIC FOR A CEMENT FAILURE IN THAT THE CEMENT WAS NOT BONDED OR ADHERENT TO THE IMPLANTS BUT WAS AFFIXED TO THE BONE. THIS CASE IS ONE OF MANY CASES OF FAILURE AFTER 1.5-2.5 YEARS WHEN USING THIS PRODUCT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15696889 ↗
• InjuryOct 21, 2022Adverse 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

  AS REPORTED IN MEDWATCH MW5112078: THE PATIENT HAD A TOTAL KNEE REPLACEMENT PERFORMED ON (B)(6) 2015. THE KNEE FAILED MUCH EARLIER THAN EXPECTED. WORK UP WAS NEGATIVE FOR INFECTION. THE RECORDS INDICATE THE ORIGINAL SURGERY WAS DONE USING STRYKER HIGH VISCOSITY BONE CEMENT FOR THE KNEE REPLACEMENT SURGERY. THE PATIENT HAD TO HAVE REVISION SURGERY AS INDICATED ON (B)(6) 2020. THE FINDINGS AT THE TIME OF SURGERY WERE THAT THE CEMENT WAS NOT BONDED OR ADHERENT TO THE IMPLANTS BUT WAS AFFIXED TO THE BONE.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 15645922 ↗
• InjurySep 20, 2022Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED IN MW5111445: "THE PATIENT HAD A TOTAL KNEE REPLACEMENT PERFORMED ON THE DATE INDICATED. THE KNEE FAILED MUCH EARLIER THAN EXPECTED. WORK UP WAS NEGATIVE FOR INFECTION. THE RECORDS INDICATE THE ORIGINAL SURGERY WAS DONE USING STRYKER HIGH VISCOSITY BONE CEMENT FOR THE KNEE REPLACEMENT SURGERY. THE PATIENT HAD TO HAVE REVISION SURGERY AS INDICATED. THE FINDINGS AT THE TIME OF SURGERY WERE CLASSIC FOR A CEMENT FAILURE IN THAT THE CEMENT WAS NOT BONDED OR ADHERENT TO THE IMPLANTS BUT WAS AFFIXED TO THE BONE. THIS CASE IS ONE OF MANY CASES OF FAILURE AFTER 1.5-2.5 YEARS WHEN USING THIS PRODUCT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15453199 ↗
• InjurySep 16, 2022Adverse 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

  AS REPORTED IN MEDWATCH MW5111445: THE PATIENT HAD A TOTAL KNEE REPLACEMENT PERFORMED ON (B)(6) 2016. THE KNEE FAILED MUCH EARLIER THAN EXPECTED. WORK UP WAS NEGATIVE FOR INFECTION. THE RECORDS INDICATE THE ORIGINAL SURGERY WAS DONE USING STRYKER HIGH VISCOSITY BONE CEMENT FOR THE KNEE REPLACEMENT SURGERY. THE PATIENT HAD TO HAVE REVISION SURGERY AS INDICATED ON (B)(6) 2020. THE FINDINGS AT THE TIME OF SURGERY WERE THAT THE CEMENT WAS NOT BONDED OR ADHERENT TO THE IMPLANTS BUT WAS AFFIXED TO THE BONE.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 15435658 ↗
• InjuryJul 12, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  PATIENT REPORTED UPCOMING LEFT KNEE REVISION (SCHEDULED ON (B)(6) 2022) DUE TO LOOSENING. PATIENT REPORTED A SUCCESSFUL PRIMARY SURGERY UNTIL (B)(6) 2022 (IMPLANTED ON (B)(6) 2017) WHERE SHE NOTICED A "LUMP" BEHIND HER LEFT KNEE. PATIENT ALLEGES SURGEON NOTED LOOSENING AND "LEAKING" OF CEMENT. PATIENT DID NOT REPORT MANUFACTURER OF THE KNEE IMPLANTS ASIDE FROM THE CEMENT. PATIENT WANTS COMPENSATION AND IS IN THE PROCESS OF RETAINING AN ATTORNEY.

  Patient problems: Arthralgia; Joint Laxity

  MAUDE report 14985768 ↗
• InjuryJul 7, 2022Loss of Osseointegration; Loss of Osseointegration

  PATIENT REPORTED UPCOMING LEFT KNEE REVISION (SCHEDULED (B)(6) 2022) DUE TO LOOSENING. PATIENT REPORTED A SUCCESSFUL PRIMARY SURGERY UNTIL APRIL 2022 WHERE SHE NOTICED A "LUMP" BEHIND HER LEFT KNEE. PATIENT ALLEGES SURGEON NOTED LOOSENING AND "LEAKING" OF CEMENT. PATIENT DID NOT REPORT MANUFACTURER OF THE KNEE IMPLANTS ASIDE FROM THE CEMENT. PATIENT NOTED SURGEON ADVISED OF A POTENTIAL STRYKER RECALL ON THE CEMENT AND PATIENT WOULD LIKE TO KNOW IF PART OF A RECALL. PATIENT WANTS COMPENSATION AND IS IN THE PROCESS OF RETAINING AN ATTORNEY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14951979 ↗
• InjuryMay 10, 2022Unstable; Unstable

  PATIENT CALLED AND IS INQUIRING ABOUT RECALL FOR HER RIGHT KNEE SURGERY ON (B)(6) 2016. UPDATE 13-APR-2022: PATIENT IS EXPERIENCING INSTABILITY. SHE HAS SEEN THREE DIFFERENT SURGEONS AND HAS UPCOMING REVISION SURGERY IN MID JUNE. PATIENT WOULD LIKE TO KNOW WHAT IMPLANTS SHE CAN USE IN HER REVISION FOR A BETTER OUTCOME.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 14344862 ↗
• InjuryMay 10, 2022Unstable; Unstable

  PATIENT CALLED AND IS INQUIRING ABOUT RECALL FOR HER RIGHT KNEE SURGERY ON (B)(6) 2016. UPDATE ON (B)(6) 2022: PATIENT IS EXPERIENCING INSTABILITY. SHE HAS SEEN THREE DIFFERENT SURGEONS AND HAS UPCOMING REVISION SURGERY IN MID (B)(6). PATIENT WOULD LIKE TO KNOW WHAT IMPLANTS SHE CAN USE IN HER REVISION FOR A BETTER OUTCOME.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 14344861 ↗
• InjuryNov 12, 2021Adverse 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 (ORIGINALLY IMPLANTED ON (B)(6) 2018). ALL IMPLANTS, A 6X9 MM CR INSERT, SIZE 5 CR FEMORAL COMPONENT, SIZE 6 PRIMARY BASEPLATE, AND 39 MM SYMMETRIC PATELLA WERE REMOVED. A WASHOUT WAS DONE AND A 6X13 MM PS INSERT, SIZE 5 PS FEMORAL COMPONENT, SIZE 6 UNIVERSAL BASEPLATE, AND NEW 39 MM PATELLA WERE IMPLANTED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 12801705 ↗
• InjuryOct 4, 2021Adverse 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

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT UNDERWENT A TKA ON (B)(6) 2015 AND DURING THE PROCEDURE SIMPLEX HV BONE CEMENT WAS UTILIZED TO CEMENT ALL COMPONENTS IN PATIENT'S KNEE. IT IS FURTHER ALLEGED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT REVISION SURGERY DUE TO TIBIAL COMPONENT LOOSENING.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 12567059 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF A RIGHT KNEE ON (B)(6) 2020. THE ORIGINAL IMPLANT DATE OF TS SURGERY WAS ON (B)(6) 2017. REASON FOR REVISION IS INFECTION. NO MORE INFORMATION IS AVAILABLE PER DOCTOR.

  Patient problems: Unspecified Infection

  MAUDE report 11160744 ↗
• InjuryDec 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. AFTER GETTING A FLU SHOT, PATIENT FELT UNWELL AND AN ACHE DEVELOPED IN HIS KNEE SHORTLY AFTER. DURING REVISION AN INFECTION WAS CONFIRMED AND A POLY SWAP WITH WASHOUT WAS PERFORMED.

  Patient problems: Arthralgia; Unspecified Infection

  MAUDE report 10967319 ↗
• InjuryNov 10, 2020Adverse 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

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT UNDERWENT A RIGHT SIDED TKA ON (B)(6) 2017 AND DURING THIS PROCEDURE THE SURGEON UTILIZED SIMPLEX G-HV BONE CEMENT TO CEMENT ALL THE COMPONENTS. IT IS FURTHER ALLEGED THAT ON (B)(6) 2019 SHE UNDERWENT A RIGHT SIDED REVISION AND THE OPERATIVE NOTES SHOW THAT THE TIBIAL COMPONENT WAS LOOSE. ADDITIONAL INFORMATION HAVE NOT BEEN PROVIDED.

  Patient problems: Arthralgia; Failure of Implant

  MAUDE report 10816022 ↗
• InjuryNov 10, 2020Adverse 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

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THROUGH A LEGAL CLAIM THAT ALLEGEDLY ON (B)(6) 2016 THE PATIENT UNDERWENT A LEFT KNEE MEDIAL COMPARTMENT MAKOPLASTY AND DURING THAT PROCEDURE SIMPLEX HV BONE CEMENT WITH GENTAMICIN WAS UTILIZED TO CEMENT ALL COMPONENTS. IT IS FURTHER ALLEGED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT REVISION SURGERY DUE TO LOOSENING OF HER TIBIAL COMPONENT. NO ADDITIONAL INFORMATION HAVE BEEN PROVIDED.

  Patient problems: Arthralgia; Failure of Implant

  MAUDE report 10815561 ↗
• InjuryNov 10, 2020Adverse 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

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THROUGH A LEGAL CLAIM THAT ALLEGEDLY ON (B)(6) 2018 THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY WITH SIMPLEX HV BONE CEMENT WITH GENTAMICIN. IT IS FURTHER ALLEGED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT REVISION SURGERY DUE TO ALLEGED LOOSENING. NO ADDITIONAL INFORMATION HAVE BEEN PROVIDED.

  Patient problems: Arthralgia; Failure of Implant

  MAUDE report 10815560 ↗