SMARTSET 3092-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 821 adverse event reports that list this exact device (DI 10603295168331), received between Jul 27, 2017 and Apr 23, 2026 — classified as 753 injuries, 68 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (570 reports).

1 other recall cover devices cleared under the same FDA submission (K023012, K033563); 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 821 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT PATIENT WAS COMPLAINING ABOUT LEG GIVING OUT. X-RAY SHOWED A VERY WORN POLY LATERALLY. WHEN THE POLY WAS REMOVED THERE WAS ALSO WEAR ON THE TIBIAL BASEPLATE. A REMOVAL OF ALL IMPLANTS EXCEPT PATELLA OCCURRED. A STEMMED ATTUNE REVISION TIBIA AND FEMUR CONSTRUCT WAS IMPLANTED. THERE WAS SOME WEAR ON THE TIBIAL BASEPLATE AND SCRATCHES ON THE ORIGINAL FEMUR WHERE THE POLY LATERALLY HAD WORN THROUGH. THE SIGMA PATELLA WAS RETAINED. DOI: (B)(6) 2010. DOR: (B)(6), 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24966127 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR ACUTE PAIN OF LEFT KNEE - PRIMARY CHRONIC PAIN OF RIGHT KNEE, OSTEOARTHRITIS OF RIGHT KNEE, ACUTE PAIN OF LEFT KNEE. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: (B)(6) 2022. DATE OF IMPLANT: (B)(6) 2017. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: INJECTED MEDICATION: YES.

  Patient problems: Pain

  MAUDE report 24459527 ↗
• MalfunctionNov 10, 2025Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT WHEN OPENING THE CEMENT PACKAGE, THE PACKAGING WITH POWDER HAD A HOLE AND, IT WAS SPILLING INTO THE SEALED PACKAGING AROUND IT. IT WAS CAUGHT BEFORE, NOT USED AND STILL SEALED. DOE: (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512448 ↗
• MalfunctionNov 10, 2025Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT WHEN OPENING THE CEMENT PACKAGE, THE PACKAGING WITH POWDER HAD A HOLE AND, IT WAS SPILLING INTO THE SEALED PACKAGING AROUND IT. IT WAS CAUGHT BEFORE, NOT USED AND STILL SEALED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512256 ↗
• MalfunctionAug 5, 2025Chemical Problem; Chemical Problem

  IT WAS REPORTED THAT DURING A PRODUCT DEMONSTRATION, THE BONE CEMENT WAS NOT DISPENSING, AND THEN THE CEMENT SYRINGE BROKE. CEMENT WAS USED WITH ELECTRIC DEMONSTRATION VACUUM PUMPS. DEMONSTRATOR CHECKED THE SYRINGE WAS SCREWED ONTO THE GUN TO MAKE SURE THAT IT WAS ON TIGHT. THE FIRST CEMENT WAS EXTRUDED ON TO DEMONSTRATORS GLOVE AND IT WAS TACKY AND STRUCK TO THE GLOVE. THE SCRUB NURSE WAS INJECTING THE MIXED BONE CEMENT INTO A DEMONSTRATION MOULD AND CEMENT WAS INITIALLY BEING DISPENSED. THE SCRUB NURSE THEN REPORTED THAT THE BONE CEMENT WAS NOT DISPENSING. THE SALES REPRESENTATIVE ATTEMPTED TO DISPENSE THE BONE CEMENT BY SQUEEZING THE GUN TRIGGER ON THE SMARTMIX GUN. A BREAKING SOUND WAS HEARD, AND THE SMARTMIX SYRINGE CAME OUT OF THE SMARTMIX GUN. THE TUBE THREAD HAD FRACTURED INTO THREE PIECES. EVENT TOOK PLACE IN A NON-CLINICAL SETTING. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22714821 ↗
• MalfunctionAug 5, 2025Chemical Problem; Chemical Problem

  IT WAS REPORTED THAT DURING A PRODUCT DEMONSTRATION, THE BONE CEMENT WAS NOT DISPENSING, AND THEN THE CEMENT SYRINGE BROKE. CEMENT WAS USED WITH ELECTRIC DEMONSTRATION VACUUM PUMPS. DEMONSTRATOR CHECKED THE SYRINGE WAS SCREWED ONTO THE GUN TO MAKE SURE THAT IT WAS ON TIGHT. THE FIRST CEMENT WAS EXTRUDED ON TO DEMONSTRATORS GLOVE AND IT WAS TACKY AND STRUCK TO THE GLOVE. THE SCRUB NURSE WAS INJECTING THE MIXED BONE CEMENT INTO A DEMONSTRATION MOULD AND CEMENT WAS INITIALLY BEING DISPENSED. THE SCRUB NURSE THEN REPORTED THAT THE BONE CEMENT WAS NOT DISPENSING. THE SALES REPRESENTATIVE ATTEMPTED TO DISPENSE THE BONE CEMENT BY SQUEEZING THE GUN TRIGGER ON THE SMARTMIX GUN. A BREAKING SOUND WAS HEARD, AND THE SMARTMIX SYRINGE CAME OUT OF THE SMARTMIX GUN. THE TUBE THREAD HAD FRACTURED INTO THREE PIECES. EVENT TOOK PLACE IN A NON-CLINICAL SETTING. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22714820 ↗
• MalfunctionAug 5, 2025Chemical Problem; Chemical Problem

  IT WAS REPORTED THAT DURING A PRODUCT DEMONSTRATION, THE BONE CEMENT WAS NOT DISPENSING, AND THEN THE CEMENT SYRINGE BROKE. CEMENT WAS USED WITH ELECTRIC DEMONSTRATION VACUUM PUMPS. DEMONSTRATOR CHECKED THE SYRINGE WAS SCREWED ONTO THE GUN TO MAKE SURE THAT IT WAS ON TIGHT. THE FIRST CEMENT WAS EXTRUDED ON TO DEMONSTRATORS GLOVE AND IT WAS TACKY AND STRUCK TO THE GLOVE. THE SCRUB NURSE WAS INJECTING THE MIXED BONE CEMENT INTO A DEMONSTRATION MOULD AND CEMENT WAS INITIALLY BEING DISPENSED. THE SCRUB NURSE THEN REPORTED THAT THE BONE CEMENT WAS NOT DISPENSING. THE SALES REPRESENTATIVE ATTEMPTED TO DISPENSE THE BONE CEMENT BY SQUEEZING THE GUN TRIGGER ON THE SMARTMIX GUN. A BREAKING SOUND WAS HEARD, AND THE SMARTMIX SYRINGE CAME OUT OF THE SMARTMIX GUN. THE TUBE THREAD HAD FRACTURED INTO THREE PIECES. EVENT TOOK PLACE IN A NON-CLINICAL SETTING. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22714816 ↗
• MalfunctionJul 7, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED A PIECE OF METAL WAS FOUND IN THE BONE CEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22411507 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2008, THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY AND TIBIAL BONE GRAFT TO ADDRESS END-STAGE OSTEOARTHRITIS. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. ON (B)(6) 2018, THE PATIENT HAD A REVISION RIGHT TOTAL KNEE REPLACEMENT TIBIAL AND FEMORAL COMPONENT TO ADDRESS FAILED RIGHT TOTAL KNEE REPLACEMENT SECONDARY TO WEAR AND SYNOVITIS. THE INDICATIONS FOR SURGERY INCLUDED EPISODES OF RECURRENT SCAR FORMATION, WHICH REQUIRED EARLY MANIPULATION AND EXCISION. A REPEAT ARTHROSCOPIC EXCISION FOR SCAR TISSUE AND THEN UNDERSIDE OF THE QUAD TENDON AND NOW WITH RECURRENT STIFFNESS AND SWELLING. RADIOGRAPHS WERE REPORTED TO SHOW A RADIOLUCENT LINE AROUND THE FEMORAL COMPONENT. DURING THE PROCEDURE, THE SURGEON OBSERVED THE POLYETHYLENE HAD BOTH FRONT SIDE AND BACKSIDE WEAR. THE SIGMA PFC KNEE HAD A RELATIVELY HIGH DEGREE OF POSTERIOR SLOPE ON THE TIBIAL SIDE AND THE FEMORAL IMPLANT DID NOT HAVE GROSS MOTION, BUT WAS RELATIVELY EASY TO REMOVE AFTER BREAKING UP THE INTERFACES WITH MINIMAL BONE INGROWTH INTO THE INGROWTH SURFACES ON THE BACKSIDE OF THE IMPLANT. IT WAS NOTED THAT THE BACKSIDE OF THE IMPLANTS HAVE SMALL AREAS OF SPOT WELDING, BUT THE REMA

  Patient problems: Adhesion(s); Muscular Rigidity; Swelling/ Edema; Synovitis

  MAUDE report 22122143 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2008, THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY AND TIBIAL BONE GRAFT TO ADDRESS END-STAGE OSTEOARTHRITIS. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. ON (B)(6) 2018, THE PATIENT HAD A REVISION RIGHT TOTAL KNEE REPLACEMENT TIBIAL AND FEMORAL COMPONENT TO ADDRESS FAILED RIGHT TOTAL KNEE REPLACEMENT SECONDARY TO WEAR AND SYNOVITIS. THE INDICATIONS FOR SURGERY INCLUDED EPISODES OF RECURRENT SCAR FORMATION, WHICH REQUIRED EARLY MANIPULATION AND EXCISION. A REPEAT ARTHROSCOPIC EXCISION FOR SCAR TISSUE AND THEN UNDERSIDE OF THE QUAD TENDON AND NOW WITH RECURRENT STIFFNESS AND SWELLING. RADIOGRAPHS WERE REPORTED TO SHOW A RADIOLUCENT LINE AROUND THE FEMORAL COMPONENT. DURING THE PROCEDURE, THE SURGEON OBSERVED THE POLYETHYLENE HAD BOTH FRONT SIDE AND BACKSIDE WEAR. THE SIGMA PFC KNEE HAD A RELATIVELY HIGH DEGREE OF POSTERIOR SLOPE ON THE TIBIAL SIDE AND THE FEMORAL IMPLANT DID NOT HAVE GROSS MOTION BUT WAS RELATIVELY EASY TO REMOVE AFTER BREAKING UP THE INTERFACES WITH MINIMAL BONE INGROWTH INTO THE INGROWTH SURFACES ON THE BACKSIDE OF THE IMPLANT. IT WAS NOTED THAT THE BACKSIDE OF THE IMPLANTS HAVE SMALL AREAS OF SPOT WELDING, BUT THE REMAI

  Patient problems: Adhesion(s); Muscular Rigidity; Swelling/ Edema; Synovitis

  MAUDE report 22122142 ↗
• InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. DATE OF EVENT: 8/NOV/2024. DEVICE LOCATION: LEFT. ON (B)(6) 2024, THE PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS LEFT KNEE ARTHRITIS. THE INDICATIONS FOR SURGERY INCLUDED A LARGE POSTEROLATERAL TIBIAL DEFECT AND MARKED VALGUS DEFORMITY WITH A HYPOPLASTIC LATERAL FEMORAL CONDYLE. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE, INCLUDING DEPUY PATELLA. CLINICAL ADVERSE EVENT RECEIVED FOR ACUTE DEEP VEIN. THROMBOSIS (DVT) OF LEFT LOWER EXTREMITY (PAIN, SEVERE). DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: PROBABLY. DATE OF IMPLANT: (B)(6) 2024. TREATMENT/IMPACT: READMITTED ON (B)(6) 2024.

  Patient problems: Pain; Thrombosis/Thrombus

  MAUDE report 21026132 ↗
• InjuryDec 13, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE SURGEON BELIEVES HE EXTENDED THE KNEE PRIOR TO CEMENT HARDENING WHICH INDUCED ANTERIOR SLOPE INTO THE TIBIAL COMPONENT WHICH CAUSED LOOSENING OVER TIME.

  Patient problems: Insufficient Information

  MAUDE report 20930369 ↗
• InjuryNov 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND REVIEWED BY A CLINICIAN; ON (B)(6) 2024, THE PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS LEFT KNEE ARTHRITIS. THE INDICATIONS FOR SURGERY INCLUDED A LARGE POSTEROLATERAL TIBIAL DEFECT AND MARKED VALGUS DEFORMITY WITH A HYPOPLASTIC LATERAL FEMORAL CONDYLE. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE, INCLUDING DEPUY PATELLA. PAST MEDICAL DIAGNOSIS: DEPRESSION, HYPERTENSION, HYPOTHYROIDISM, MONOCLONAL GAMMOPATHY OF UNKNOWN SIGNIFICANCE, MALIGNANT NEOPLASM OF RIGHT BREAST.

  Patient problems: Pain; Thrombosis/Thrombus

  MAUDE report 20773988 ↗
• InjuryNov 12, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2018, PATIENT REPORTEDLY RECEIVED A LEFT TOTAL KNEE REVISION TO ADDRESS PAIN, FLEXION INSTABILITY, AND ASEPTIC LOOSENING OF THE TIBIAL BASEPLATE. SURGEON IDENTIFIED THAT ALTHOUGH THE FEMUR WAS WELL-FIXED, THE FLEXION INSTABILITY REQUIRED REVISION OF THE FEMUR AND TIBIA. THE TIBIAL TRAY WAS LOOSE--INTERFACE UNSPECIFIED. THE PATELLA WAS FOUND TO BE WELL-FIXED AND WAS RETAINED. FEMUR WAS REPLACED WITH DEPUY ATTUNE REVISION FEMUR SIZE 6, A 30MM SLEEVE, AND 4MM DISTAL AND POSTERIOR AUGMENTS, AND A 14 X 60 FEMORAL STEM. THE TIBIAL TRAY WAS REPLACED WITH AN ATTUNE REVISION TIBIAL TRAY SIZE 6, A 37MM SLEEVE, AND 14 X 60 TIBIAL STEM. THERE WERE NO COMPLICATIONS. DOI: (B)(6) 2015. DOR: (B)(6) 2018. LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 20665324 ↗
• InjuryNov 7, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2016, PATIENT RECEIVED AN ATTUNE RIGHT TOTAL KNEE ARTHROPLASTY TO ADDRESS PRIMARY OSTEOARTHRITIS. THEY RECEIVED A SIZE 7 POSTERIOR STABILIZED FEMUR, A SIZE 6 TIBIAL TRAY, A 6MM THICK INSERT, AND 38MM PATELLA, ALL USING DEPUY SMARTSET HV CEMENT. THERE WERE NO COMPLICATIONS. ON (B)(6) 2020, PATIENT'S RIGHT KNEE WAS REVISED TO ADDRESS ASEPTIC IMPLANT LOOSENING OF TIBIA AND FEMUR. INTRAOPERATIVELY, THE TIBIAL BASEPLATE WAS FOUND TO BE LOOSE AT THE CEMENT TO IMPLANT INTERFACE; SURGEON REPORTED THAT THERE WAS NO CEMENT ADHERED/BONDED TO THE BACKSIDE OF THE TIBIAL TRAY AT ALL. THE FEMUR WAS ALSO LOOSE AND EXPLANTED AS WELL; THERE WAS CEMENT BONDED TO THE FEMUR COMPONENT. THE FEMUR LOOSENING INTERFACE WAS BOTH CEMENT TO IMPLANT AND CEMENT TO BONE LOOSENING. THE PATELLA COMPONENT WAS WELL-FIXED AND RETAINED. SURGEON RE-IMPLANTED COMPETITOR PRODUCTS, WITH NO REPORTED COMPLICATIONS. DOI: (B)(6) 2016. DOR: (B)(6) 2020. RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20631264 ↗
• InjuryOct 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DSJ-2016-03. CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE ARTHROFIBROSIS DEVICE AND PROCEDURE(RELATEDNESS): DEVICE RELATED: DEFINITELY NOT PROCEDURE RELATED: DEFINITELY DATE OF EVENT: 10 APR 2019 . DEVICE LOCATION: RIGHT TREATMENT/IMPACT: : CLOSED REDUCTION/MANIPULATION.

  Patient problems: Adhesion(s)

  MAUDE report 20471405 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENTS RECEIVED FOR DEEP VEIN THROMBOSIS OF LEFT LOWER EXTREMITY DEVICE AND PROCEDURE(RELATEDNESS) DEVICE RELATED: POSSIBLY, PROCEDURE RELATED: POSSIBLY, DATE OF EVENT: 31 JAN 2019, DATE OF IMPLANT: (B)(6) 2018, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: ORAL MEDICATION

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20444650 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENTS RECEIVED FOR DEEP VEIN THROMBOSIS OF LEFT LOWER EXTREMITY DEVICE AND PROCEDURE(RELATEDNESS) DEVICE RELATED: POSSIBLY PROCEDURE RELATED: POSSIBLY DATE OF EVENT: 31 JAN 2019 DATE OF IMPLANT: (B)(6) 2018 DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: LEFT. . TREATMENT/IMPACT: ORAL MEDICATION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20444105 ↗
• InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR: DID SUBJECT REPORT ANY NEW AES OR ANY UPDATES TO AN EXISTING AE AT THIS EVALUATION? : YES. DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: NO INFORMATION PROVIDED. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: KNEE; NO INFORMATION PROVIDED. TREATMENT/IMPACT: NO REMOVAL/EXCHANGE/REVISION. ADDITIONAL EVENT INFORMATION CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE EFFUSION. DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: POSSIBLY. PROCEDURE RELATED: POSSIBLY. DATE OF EVENT: 29 OCT 2019. DATE OF IMPLANT: (B)(6) 2019. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT KNEE. TREATMENT/IMPACT: ASPIRATION/DRAINAGE; RECOVERED/RESOLVED WITH NO RESIDUAL EFFECTS ON (B)(6) 2019.

  Patient problems: Swelling/ Edema

  MAUDE report 20332965 ↗
• InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(4). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR: DID SUBJECT REPORT ANY NEW AES OR ANY UPDATES TO AN EXISTING AE AT THIS EVALUATION? : YES. DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: NO INFORMATION PROVIDED PROCEDURE RELATED: NO INFORMATION PROVIDED DATE OF EVENT: NO INFORMATION PROVIDED DATE OF IMPLANT: NO INFORMATION PROVIDED DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: KNEE; NO INFORMATION PROVIDED. TREATMENT/IMPACT: NO REMOVAL/EXCHANGE/REVISION. ADDITIONAL EVENT INFORMATION. CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE EFFUSION. DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: POSSIBLY. PROCEDURE RELATED: POSSIBLY. DATE OF EVENT: 29 OCT 2019. DATE OF IMPLANT: (B)(6) 2019. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT KNEE. TREATMENT/IMPACT: ASPIRATION/DRAINAGE; RECOVERED/RESOLVED WITH NO RESIDUAL EFFECTS ON (B)(6) 2019.

  Patient problems: Swelling/ Edema

  MAUDE report 20332956 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE EFFUSION: DEVICE (RELATEDNESS): POSSIBLY. PROCEDURE (RELATEDNESS): POSSIBLY. DATE OF EVENT: 29 OCT 2019. DATE OF IMPLANT: (B)(6) 2019. DATE OF REVISION: BLANK. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: ASPIRATION/DRAINAGE.

  Patient problems: Swelling/ Edema

  MAUDE report 20293207 ↗
• MalfunctionAug 9, 2024Device Damaged Prior to Use; Difficult to Open or Remove Packaging Material; Device Damaged Prior to Use; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING SETUP FOR THE CASE THAT MORNING, THE CIRCULATOR HAD OPENED A BAG OF OUR CEMENT AND FOUND IT TO BE BUSTED. I HAD GRABBED A FEW BOXES TO REPLACE IT, BUT THE POWDER PACKAGING IN ALL FOUR OF THEM WAS ALSO BUSTED. IT APPEARED THAT THERE WAS AN ISSUE WITH THE SEAL NOT CLOSING ALL THE WAY. THEY ALL HAD THE SAME LOT NUMBER. THERE HAD BEEN NO DELAY TO THE CASE OR ISSUE WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19951875 ↗
• MalfunctionAug 9, 2024Device Damaged Prior to Use; Difficult to Open or Remove Packaging Material; Device Damaged Prior to Use; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING SETUP FOR THE CASE THAT MORNING, THE CIRCULATOR HAD OPENED A BAG OF OUR CEMENT AND FOUND IT TO BE BUSTED. I HAD GRABBED A FEW BOXES TO REPLACE IT, BUT THE POWDER PACKAGING IN ALL FOUR OF THEM WAS ALSO BUSTED. IT APPEARED THAT THERE WAS AN ISSUE WITH THE SEAL NOT CLOSING ALL THE WAY. THEY ALL HAD THE SAME LOT NUMBER. THERE HAD BEEN NO DELAY TO THE CASE OR ISSUE WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19951728 ↗
• MalfunctionAug 9, 2024Device Damaged Prior to Use; Difficult to Open or Remove Packaging Material; Device Damaged Prior to Use; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING SETUP FOR THE CASE THAT MORNING, THE CIRCULATOR HAD OPENED A BAG OF OUR CEMENT AND FOUND IT TO BE BUSTED. I HAD GRABBED A FEW BOXES TO REPLACE IT, BUT THE POWDER PACKAGING IN ALL FOUR OF THEM WAS ALSO BUSTED. IT APPEARED THAT THERE WAS AN ISSUE WITH THE SEAL NOT CLOSING ALL THE WAY. THEY ALL HAD THE SAME LOT NUMBER. THERE HAD BEEN NO DELAY TO THE CASE OR ISSUE WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19951681 ↗
• MalfunctionAug 9, 2024Device Damaged Prior to Use; Difficult to Open or Remove Packaging Material; Device Damaged Prior to Use; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING SETUP FOR THE CASE THAT MORNING, THE CIRCULATOR HAD OPENED A BAG OF OUR CEMENT AND FOUND IT TO BE BUSTED. I HAD GRABBED A FEW BOXES TO REPLACE IT, BUT THE POWDER PACKAGING IN ALL FOUR OF THEM WAS ALSO BUSTED. IT APPEARED THAT THERE WAS AN ISSUE WITH THE SEAL NOT CLOSING ALL THE WAY. THEY ALL HAD THE SAME LOT NUMBER. THERE HAD BEEN NO DELAY TO THE CASE OR ISSUE WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19951660 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023012, K033563. One submission often covers many models, so check the product and lot details in each record.

• Z-1246-2015 · Feb 11, 2015 · Terminated
  SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used for securing a metal or polymeric prosthesis