Simplex 6192-1-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327128451), received between Jun 10, 2019 and May 29, 2025 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT UPON INSPECTION, THE STERILIZATION DOT OF 2 DOSES OF CEMENT WERE YELLOW/ GOLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22103698 ↗
• MalfunctionMay 29, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT UPON INSPECTION, THE STERILIZATION DOT OF 2 DOSES OF CEMENT WERE YELLOW/ GOLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22103695 ↗
• InjuryMay 19, 2025Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO FEMORAL LOOSENING. THE FEMUR AND INSERT WERE REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22042709 ↗
• InjuryMay 19, 2025Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO FEMORAL LOOSENING. THE FEMUR AND INSERT WERE REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22042703 ↗
• InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PT CALLED TO REPORT THAT THEIR HUSBAND HAD A LEFT PARTIAL HIP REPLACEMENT THAT WAS DONE ON (B)(6) OF 2019 AND IT WAS FAILING. THEY WANTED TO KNOW IF THERE HAD BEEN A RECALL. THE PROTHESIS WAS A COMPETITOR THE ONLY STRYKER PRODUCT WAS THE CEMENT. RECALL ENQUIRY.

  Patient problems: Failure of Implant

  MAUDE report 20662617 ↗
• InjuryOct 8, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO LOOSENING OF THE CEMENT MANTLE FOR AN EXETER STEM DUE TO FAILURE OF THE CEMENT TO INTERDIGITATE WITH THE PATIENT'S POOR QUALITY BONE (REP CONFIRMED THERE WAS NO FRACTURE OF THE BONE OR ANY IMPLANTS). THIS LED TO STEM SUBSIDENCE. AN EXETER STEM, CERAMIC HEAD, AND 36E 0° INSERT WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH CABLES AND SLEEVES, ANOTHER CERAMIC HEAD, AND ANOTHER 36E 0° INSERT. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD AND LINER, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20395464 ↗
• InjuryOct 8, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO LOOSENING OF THE CEMENT MANTLE FOR AN EXETER STEM DUE TO FAILURE OF THE CEMENT TO INTERDIGITATE WITH THE PATIENT'S POOR QUALITY BONE (REP CONFIRMED THERE WAS NO FRACTURE OF THE BONE OR ANY IMPLANTS). THIS LED TO STEM SUBSIDENCE. AN EXETER STEM, CERAMIC HEAD, AND 36E 0° INSERT WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH CABLES AND SLEEVES, ANOTHER CERAMIC HEAD, AND ANOTHER 36E 0° INSERT. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD AND LINER, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20395462 ↗
• InjurySep 11, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO PAINFUL FAILED LEFT TOTAL KNEE ARTHROPLASTY. UPDATE FROM MED REVIEW: "REVISION LEFT TKA - FEMORAL AND TIBIAL COMPONENTS' FOR "PAINFUL, FAILED LEFT TKA WITH INADEQUATE FIXATION OF TIBIAL COMPONENT." " ...TIBIAL AND FEMORAL COMPONENTS REMOVED WITH OSTEOTOME - REVISED TO CEMENTED, MODULAR REVISION COMPONENTS. UNCOMPLICATED SURGERY - PATELLA NOT MENTIONED."

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 12457634 ↗
• MalfunctionJul 11, 2019Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  6192-1-010 DAMAGED DURING SHIPMENT ((B)(6)) TO CUSTOMER. 3 VIALS BROKEN AND LEAKED ON REMAINING DOSES. UPDATE: "ONE COMPLETE TEN PACK. CUSTOMER REPORTED DAMAGED OUTER BOX. 3 VIALS WERE BROKEN AND LEAKED ON REMAINING 7 DOSES. ODOR WAS COMING FROM THE PRODUCT WHEN RECEIVED. TEN PACK WAS RECEIVED IN A SHIPPER/OUTER BOX AND WAS PACKED APPROPRIATELY TO MINIMIZE MOVEMENT. A REPORT WAS FILED WITH (B)(6)."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8780008 ↗
• InjuryJun 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED ON MEDWATCH (MW5086208) "PARTIAL SHOULDER REPLACEMENT, 2018. PHYSICAL THERAPY BEGINS WITHIN 2 WEEKS OF SURGERY AND LASTS UNTIL LATE 2018. HAD VERY GOOD RANGE OF MOTION AND STRENGTH WITH ONE EXCEPTION: I COULD NOT SUSTAIN A DIRECT LOAD TO SHOULDER. CONDITION APPEARED FROM THE BEGINNING AND NEVER IMPROVED; IT IS BELIEVED THAT THIS WAS THE INDICATOR THAT THE GLENOID COMPONENT HAD DISLODGED VERY EARLY ON, WITHIN A MONTH OR LESS. SECOND SURGERY: 2018, TO DETERMINE CAUSE OF DRAINAGE FROM SUTURE LINE IN SHOULDER; THE PREVIOUS INCISION WAS COMPLETELY REOPENED AND PROBED TO THE CAPSULE. SEVERAL SUTURE ABSCESSES WERE FORMING BY REMAINING VICRYL SUTURE THAT HADN¿T FINISHED SPITTING. NO EVIDENCE OF SINUS TRACT FORMATION, DEEP SPACE INFECTION OR INVOLVEMENT OF THE JOINT CAPSULE. LATE 2018: TOPICAL ABSCESS IN SUTURE LINE BEGINS TO FORM; VISIT DOCTOR TWICE IN DECEMBER BEFORE SURGERY. DOCTOR CONFUSED AS TO WHY MY CONDITION PERSISTED AFTER THE COMPLETE CLEANING FROM PREVIOUS SURGERY. THIRD SURGERY: 2018. NO CAPSULAR INFECTION/ BACTERIA FOUND; LOOSE COMPONENT DETECTED. DOCTOR AT THIS TIME STATED HE BELIEVED THE COMPONENT HAD LOOSENED DUE TO BACTERIA BREAKING THE BOND OF THE CEMENT TO THE

  Patient problems: Injury

  MAUDE report 8684595 ↗