NA 3332-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 197 adverse event reports that list this exact device (DI 10603295168638), received between Dec 29, 2010 and Sep 19, 2024 — classified as 4 deaths, 173 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (79 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 197 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ADHESION. DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: POSSIBLY RELATED. DATE OF EVENT: 28 AUG 2024. DATE OF IMPLANT: INFORMATION NOT PROVIDED. DATE OF REVISION: INFORMATION NOT PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: INFORMATION NOT PROVIDED. ADDITIONAL EVENT INFORMATION: (B)(6) 2024 MEDICAL RECORDS NOTE THAT THE PATIENT WAS STRUGGLING WITH HINGED KNEE. RADIOGRAPH SHOWS A WELL-PLACED RIGHT HINGED KNEE. THE CLINICAL IMPRESSION IS THAT THE PATIENT IS DOING POORLY WITH THEIR MOTION, WITH VERY POOR PAIN TOLERANCE. THE PATIENT IS QUITE STIFF AND THAT IS VERY UNUSUAL FOR A HINGE. THE PLAN IS TO SCHEDULE A GENTLE MANIPULATION.

  Patient problems: Adhesion(s); Joint Laxity; Loss of Range of Motion; Muscular Rigidity; Pain

  MAUDE report 20256063 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR ADHESIONS: IS THIS EVENT RELATED TO THE STUDY DEVICE? NOT RELATED. IS THIS EVENT RELATED TO THE STUDY PROCEDURE? REMOTE POSSIBILITY. DATE OF EVENT: 28/AUG/2024. ADDITIONAL EVENT INFORMATION: CLINIC NOTE ADDED: (B)(6) 2024. ON (B)(6) 2024, MEDICAL RECORDS NOTE, THE PATIENT IS FOUR YEARS POST RIGHT TOTAL KNEE ARTHROPLASTY. THE PATIENT WAS NOTED, TO HAVE ARTHROFIBROSIS KNEE WITH PAIN AND STIFFNESS. THE PATIENT HAD A SCAR TISSUE SURGERY WITH OPEN RESECTION, POLY SWAP IN THE PAST. THE PATIENT THEN FELL AND HAD REGRESSION AND RETURN OF ARTHROFIBROSIS. THE PATIENT HAS INCREASED PAIN, DIFFICULT TIME WITH MOBILITY. AN ASPIRATION OF KNEE WAS PERFORMED. AND NEGATIVE FOR ANY TIME OF BACTERIAL INFECTION. THE SURGEON SUGGESTED, TOTAL KNEE ARTHROPLASTY REVISION FOR ARTHROFIBROSIS.

  Patient problems: Adhesion(s); Fall; Loss of Range of Motion; Muscular Rigidity; Pain

  MAUDE report 20223280 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DISLOCATION - FEMORAL/TIBIAL. DEVICE IS NOT RELATED . PROCEDURE RELATEDNESS: POSSIBLY. DEVICE LOCATION: RIGHT. ADDITIONAL EVENT INFORMATION: ON (B)(6) 2024 MEDICAL RECORDS NOTE THE PATIENT HAD DISLOCATED RIGHT KNEE AFTER SLIPPING AND HYPEREXTEDING THE KNEE. THE PHYSICAL EXAMINATION NOTES THAT THE MCL IS COMPLETELY TORN THE PATIENT IS TO BE SCHEDULED FOR A REVISION. DEPUY COMPONENTS ARE CURRENTLY IMPLANTED.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 19927640 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEPUY CMW 3 BONE CEMENT 40 G WAS USED FOR HIP REPLACEMENT ON PATIENT. AFTER THE REPLACEMENT THERE STARTED SOME SERIOUS COMPLICATIONS, INCLUDING INFECTION ETC. DUE TO COMPLICATIONS THE PATIENT WAS AGAIN OPERATED TO REMOVE THE MATERIALS FIXED. SUBSEQUENTLY THE PATIENT'S CONDITION WORSENED AND WAS BED RIDDEN. SO THE CLAIM WAS FILED IN 2019 BUT WAS REJECTED STATING COMMITTEE IS DIRECTED TO DEAL WITH ONLY ASR HIP IMPLANT.

  Patient problems: Unspecified Infection

  MAUDE report 19360790 ↗
• InjuryMar 4, 2024Fracture; Fracture

  SUBJECT ID: (B)(6); STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR CEMENT DEBRIS DEGENERATION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2018; DATE OF EVENT: (B)(6) 2024; (LEFT KNEE). TREATMENT: REVISION; PATELLA AND INSERT WERE REVISED.

  Patient problems: Insufficient Information

  MAUDE report 18826007 ↗
• MalfunctionSep 12, 2023Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT ON (B)(6) 2023 ,THE HOSPITAL CEMENT WAS EXPIRED ON 31 MAY 2023. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN. WAS PROCEDURE SUCCESSFULLY COMPLETED?UNKNOWN. WERE FRAGMENTS GENERATED? UNKNOWN. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES? WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF : NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: Insufficient Information

  MAUDE report 17728837 ↗
• MalfunctionJul 24, 2023Expiration Date Error; Expiration Date Error

  DEVICE REPORT FROM DEPUY SYNTHES SPAIN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH DEPUY CMW 3 40G ON (B)(6) 2023. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17383750 ↗
• MalfunctionJul 19, 2023Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT THE PRODUCT WAS IMPLANTED WITH AN EXPIRATION DATE MAY, 31, 2023.

  Patient problems: Insufficient Information

  MAUDE report 17353607 ↗
• InjuryJul 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE SAME SURGERY ON (B)(6) 2023, THE SURGEON ADDRESSED COMPLAINTS OF RIGHT PATELLAR CLUNK BY PERFORMING A SCOPE OF THE RIGHT KNEE. HE IDENTIFIED HYPERTROPHIC SCAR ON THE UNDERSURFACE OF THE QUADRICEPS TENDON, WHICH WAS REMOVED. SCAR WAS ALSO REMOVED AROUND THE PERIPHERY OF THE PATELLA, WHICH ALLOWED THE PATELLA TO TRACK NICELY. NO IMPLANTS WERE REVISED ON THE RIGHT SIDE. DOI: (B)(6) 2016. (B)(6) 2022 (INSERT). DOE: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Unspecified Tissue Injury

  MAUDE report 17265605 ↗
• InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INCREASED KNEE PAIN AND DEEP INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2017, DATE OF EVENT: UNK 2019, (LEFT KNEE). TREATMENT: EXPLANT OF ALL COMPONENTS, EIGHT WEEKS OF ANTIBIOTICS (RE-IMPLANTATION OF COMPONENTS PLANNED AFTER ANTIBIOTIC TREATMENT).

  Patient problems: Pain; Unspecified Infection

  MAUDE report 16918867 ↗
• MalfunctionMay 5, 2023Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT A PRODUCT WAS IMPLANTED ON (B)(6) 2023 THAT HAD AN EXPIRATION DATE OF 31/03/23.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16876157 ↗
• MalfunctionApr 17, 2023Expiration Date Error; No Apparent Adverse Event; Expiration Date Error; No Apparent Adverse Event

  THE (B)(6) 2023 H VILLALBA HAS IMPLANTED A PRODUCT WITH AN EXPIRATION DATE THE 31/10/22.

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

  MAUDE report 16750762 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SEVERE PAIN. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2019, DATE OF REVISION: UNK, DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: REVISION (REVISED COMPONENTS NOT SPECIFIED).

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Swelling/ Edema

  MAUDE report 16580991 ↗
• InjuryFeb 27, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN WITH WALKING, ABNORMAL X-RAYS, AND TIBIAL LOOSENING/MIGRATION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF REVISION: UNK. DATE OF IMPLANT: (B)(6) 2017. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE). TREATMENT: REVISION (COMPONENTS REVISED UNSPECIFIED).

  Patient problems: Pain

  MAUDE report 16442865 ↗
• MalfunctionFeb 1, 2023Expiration Date Error; Expiration Date Error

  THE (B)(6) 2023 (B)(6) HAS IMPLANTED A PRODUCT WITH AN EXPIRATION DATE THE (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 16277003 ↗
• InjuryJan 3, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  CLINICAL ADVERSE EVENT RECEIVED FOR CONTINUED PAIN AND MIGRATION/LOOSENING OF TIBIA. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2016. DATE OF EVENT: (B)(6) 2022. (RIGHT KNEE). TREATMENT: REVISION; TIBIAL AND INSERT WERE REVISED

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 16089178 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INFECTED KNEE, DEEP INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2018. DATE OF REVISION: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, PATELLA, TIBIAL, AND INSERT WERE REVISED.

  Patient problems: Erythema; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16015921 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR STIFFNESS AND HEMARTHROSIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2015. DATE OF EVENT: (B)(6) 2022. (RIGHT KNEE). TREATMENT: ASPIRATION OF 10ML OF BLOODY FLUID, SENT FOR SYNOVASURE.

  Patient problems: Fall; Hemorrhage/Blood Loss/Bleeding; Joint Laxity; Loss of Range of Motion; Muscular Rigidity; Pain

  MAUDE report 16014645 ↗
• InjuryDec 16, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2020, THE PATIENT HAD A REVISION LEFT TKA BOTH COMPONENTS AND PATELLA, TO ADDRESS FAILED TKA WITH ASEPTIC LOOSENING AND FRACTURE OF THE PREVIOUS REVISION TIBIAL STEM. DURING THE PROCEDURE THE SURGEON OBSERVED AN ABUNDANCE OF INTRA-ARTICULAR FIBROSIS/FIBROTIC TISSUE, THE TIBIAL TRAY WAS GROSSLY LOOSE (UNCEMENTED), A LARGE DEFECT OF THE MEDIAL TIBIAL PLATEAU, AND FRACTURE OF THE STEM AT THE JUNCTION BETWEEN THE STEM AND THE TIBIAL BASEPLATE. COMPETITOR COMPONENTS, INCLUDING PATELLA WERE IMPLANTED DURING THIS PROCEDURE, ALONG WITH DEPUY CEMENT. ON (B)(6) 2022 MEDICAL RECORDS NOTE THE PATIENT HAS LOOSENING AND SUBSIDENCE AND INSTABILITY/LIGAMENTOUS LAXITY IN THE TKA ALONG WITH PAIN ON (B)(6) 2022 THE PATIENT HAD A REVISION LEFT TKA TIBIAL COMPONENT, PROPHYLACTIC PLATING OF LEFT TIBIA TO ADDRESS RECURRENT LEFT TKA FAILURE WITH RECURRENT VARUS TIBIAL COLLAPSE. COMPETITOR COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE . THE PATIENT¿S HISTORY INCLUDED MULTIPLE-REVISIONS OF THE LEFT KNEE. THE PATIENT HAS HAD RECURRENT BREAKAGE OF HIS TIBIAL BASEPLATE FROM THE UNCEMENTED TIBIAL STEM. DURING THE SURGERY, THE SURGEON REMARKED THAT THERE WERE NO SIGNS OF INFECTION. THERE WAS SYNOVITI

  Patient problems: Joint Laxity; Pain; Synovitis

  MAUDE report 15994669 ↗
• InjuryDec 16, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2020, THE PATIENT HAD A REVISION LEFT TKA BOTH COMPONENTS AND PATELLA, TO ADDRESS FAILED TKA WITH ASEPTIC LOOSENING AND FRACTURE OF THE PREVIOUS REVISION TIBIAL STEM. DURING THE PROCEDURE THE SURGEON OBSERVED AN ABUNDANCE OF INTRA-ARTICULAR FIBROSIS/FIBROTIC TISSUE, THE TIBIAL TRAY WAS GROSSLY LOOSE (UNCEMENTED), A LARGE DEFECT OF THE MEDIAL TIBIAL PLATEAU, AND FRACTURE OF THE STEM AT THE JUNCTION BETWEEN THE STEM AND THE TIBIAL BASEPLATE. COMPETITOR COMPONENTS, INCLUDING PATELLA WERE IMPLANTED DURING THIS PROCEDURE, ALONG WITH DEPUY CEMENT. ON (B)(6) 2022 MEDICAL RECORDS NOTE THE PATIENT HAS LOOSENING AND SUBSIDENCE AND INSTABILITY/LIGAMENTOUS LAXITY IN THE TKA ALONG WITH PAIN. ON (B)(6) 2022 THE PATIENT HAD A REVISION LEFT TKA TIBIAL COMPONENT, PROPHYLACTIC PLATING OF LEFT TIBIA TO ADDRESS RECURRENT LEFT TKA FAILURE WITH RECURRENT VARUS TIBIAL COLLAPSE. COMPETITOR COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. THE PATIENT¿S HISTORY INCLUDED MULTIPLE-REVISIONS OF THE LEFT KNEE. THE PATIENT HAS HAD RECURRENT BREAKAGE OF HIS TIBIAL BASEPLATE FROM THE UNCEMENTED TIBIAL STEM. DURING THE SURGERY, THE SURGEON REMARKED THAT THERE WERE NO SIGNS OF INFECTION. THERE WAS SYNOVITI

  Patient problems: Joint Laxity; Pain; Synovitis

  MAUDE report 15994668 ↗
• InjuryDec 16, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2020, THE PATIENT HAD A REVISION LEFT TKA BOTH COMPONENTS AND PATELLA, TO ADDRESS FAILED TKA WITH ASEPTIC LOOSENING AND FRACTURE OF THE PREVIOUS REVISION TIBIAL STEM. DURING THE PROCEDURE THE SURGEON OBSERVED AN ABUNDANCE OF INTRA-ARTICULAR FIBROSIS/FIBROTIC TISSUE, THE TIBIAL TRAY WAS GROSSLY LOOSE (UNCEMENTED), A LARGE DEFECT OF THE MEDIAL TIBIAL PLATEAU, AND FRACTURE OF THE STEM AT THE JUNCTION BETWEEN THE STEM AND THE TIBIAL BASEPLATE. COMPETITOR COMPONENTS, INCLUDING PATELLA WERE IMPLANTED DURING THIS PROCEDURE, ALONG WITH DEPUY CEMENT. ON (B)(6) 2022 MEDICAL RECORDS NOTE THE PATIENT HAS LOOSENING AND SUBSIDENCE AND INSTABILITY/LIGAMENTOUS LAXITY IN THE TKA ALONG WITH PAIN ON (B)(6) 2022 THE PATIENT HAD A REVISION LEFT TKA TIBIAL COMPONENT, PROPHYLACTIC PLATING OF LEFT TIBIA TO ADDRESS RECURRENT LEFT TKA FAILURE WITH RECURRENT VARUS TIBIAL COLLAPSE. COMPETITOR COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE . THE PATIENT¿S HISTORY INCLUDED MULTIPLE-REVISIONS OF THE LEFT KNEE. THE PATIENT HAS HAD RECURRENT BREAKAGE OF HIS TIBIAL BASEPLATE FROM THE UNCEMENTED TIBIAL STEM. DURING THE SURGERY, THE SURGEON REMARKED THAT THERE WERE NO SIGNS OF INFECTION. THERE WAS SYNOVITI

  Patient problems: Joint Laxity; Pain; Synovitis

  MAUDE report 15994666 ↗
• InjuryDec 16, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2020, THE PATIENT HAD A REVISION LEFT TKA BOTH COMPONENTS AND PATELLA, TO ADDRESS FAILED TKA WITH ASEPTIC LOOSENING AND FRACTURE OF THE PREVIOUS REVISION TIBIAL STEM. DURING THE PROCEDURE THE SURGEON OBSERVED AN ABUNDANCE OF INTRA-ARTICULAR FIBROSIS/FIBROTIC TISSUE, THE TIBIAL TRAY WAS GROSSLY LOOSE (UNCEMENTED), A LARGE DEFECT OF THE MEDIAL TIBIAL PLATEAU, AND FRACTURE OF THE STEM AT THE JUNCTION BETWEEN THE STEM AND THE TIBIAL BASEPLATE. COMPETITOR COMPONENTS, INCLUDING PATELLA WERE IMPLANTED DURING THIS PROCEDURE, ALONG WITH DEPUY CEMENT. ON (B)(6) 2022 MEDICAL RECORDS NOTE THE PATIENT HAS LOOSENING AND SUBSIDENCE AND INSTABILITY/LIGAMENTOUS LAXITY IN THE TKA ALONG WITH PAIN ON (B)(6) 2022 THE PATIENT HAD A REVISION LEFT TKA TIBIAL COMPONENT, PROPHYLACTIC PLATING OF LEFT TIBIA TO ADDRESS RECURRENT LEFT TKA FAILURE WITH RECURRENT VARUS TIBIAL COLLAPSE. COMPETITOR COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE . THE PATIENT¿S HISTORY INCLUDED MULTIPLE-REVISIONS OF THE LEFT KNEE. THE PATIENT HAS HAD RECURRENT BREAKAGE OF HIS TIBIAL BASEPLATE FROM THE UNCEMENTED TIBIAL STEM. DURING THE SURGERY, THE SURGEON REMARKED THAT THERE WERE NO SIGNS OF INFECTION. THERE WAS SYNOVITI

  Patient problems: Joint Laxity; Pain; Synovitis

  MAUDE report 15994665 ↗
• InjuryDec 16, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2020, THE PATIENT HAD A REVISION LEFT TKA BOTH COMPONENTS AND PATELLA, TO ADDRESS FAILED TKA WITH ASEPTIC LOOSENING AND FRACTURE OF THE PREVIOUS REVISION TIBIAL STEM. DURING THE PROCEDURE THE SURGEON OBSERVED AN ABUNDANCE OF INTRA-ARTICULAR FIBROSIS/FIBROTIC TISSUE, THE TIBIAL TRAY WAS GROSSLY LOOSE (UNCEMENTED), A LARGE DEFECT OF THE MEDIAL TIBIAL PLATEAU, AND FRACTURE OF THE STEM AT THE JUNCTION BETWEEN THE STEM AND THE TIBIAL BASEPLATE. COMPETITOR COMPONENTS, INCLUDING PATELLA WERE IMPLANTED DURING THIS PROCEDURE, ALONG WITH DEPUY CEMENT. ON (B)(6) 2022 MEDICAL RECORDS NOTE THE PATIENT HAS LOOSENING AND SUBSIDENCE AND INSTABILITY/LIGAMENTOUS LAXITY IN THE TKA ALONG WITH PAIN. ON (B)(6) 2022 THE PATIENT HAD A REVISION LEFT TKA TIBIAL COMPONENT, PROPHYLACTIC PLATING OF LEFT TIBIA TO ADDRESS RECURRENT LEFT TKA FAILURE WITH RECURRENT VARUS TIBIAL COLLAPSE. COMPETITOR COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. THE PATIENT¿S HISTORY INCLUDED MULTIPLE-REVISIONS OF THE LEFT KNEE. THE PATIENT HAS HAD RECURRENT BREAKAGE OF HIS TIBIAL BASEPLATE FROM THE UNCEMENTED TIBIAL STEM. DURING THE SURGERY, THE SURGEON REMARKED THAT THERE WERE NO SIGNS OF INFECTION. THERE WAS SYNOVITI

  Patient problems: Joint Laxity; Pain; Synovitis

  MAUDE report 15994663 ↗
• MalfunctionNov 4, 2022Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE AFTER OPENING THE OUTER PACKAGING, THE NURSE IMMEDIATELY FOUND THAT THE PLASTIC PROTECTIVE COVER OF THE GLASS BOTTLE IN THE MEDICINE BOX WAS BROKEN, AND IMMEDIATELY REPLACED A NEW PACK OF BONE CEMENT FOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15735623 ↗
• MalfunctionNov 30, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE AMPOULE WASN'T BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12894415 ↗