ATTUNE 1506-10-009Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10603295042631), received between Nov 15, 2017 and Aug 23, 2022 — classified as 41 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (30 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 41 reports, in the reporter's own words as published by the FDA.

• InjuryAug 23, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT RECEIVED A LEFT ATTUNE PRIMARY KNEE TO TREAT END-STAGE DJD. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT ASEPTIC LOOSENING. UPON ENTERING THE JOINT, THE SURGEON CONFIRMED LOOSENING OF THE FEMORAL COMPONENT AND TIBIAL TRAY. THE FEMORAL COMPONENT WAS LOOSENED AT AN UNKNOWN INTERFACE AND REVISED. THE TIBIAL TRAY WAS GROSSLY LOOSE AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE. THERE WAS SIGNIFICANT MEDIAL TIBIAL BONE LOSS REQUIRING A COMPETITOR REVISION CONE AND SCREWS TO RECONSTRUCT THE TIBIA. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATELLA WAS WELL-FIXED AND RETAINED. THE PATIENT RECEIVED A COMPETITOR REVISION KNEE CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2018, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15275626 ↗
• InjuryMar 14, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO ASEPTIC TIBIAL LOOSENING. DEPUY CEMENT WAS USED. DOI: (B)(6) 2018; DOR: (B)(6) 2022; AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 13757791 ↗
• InjuryApr 15, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT RECEIVED PRIMARY ATTUNE TKAS TO TREAT END-STAGE DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED AND COMPETITOR CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT PAIN SECONDARY TO ASEPTIC LOOSENING. UPON ENTERING THE JOINT, FEMORAL OSTEOLYSIS WAS IDENTIFIED. THE FEMORAL COMPONENT WAS LOOSENED AT AN UNKNOWN INTERFACE AND REVISED. THE TIBIAL TRAY WAS LOOSENED AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE LOOSENED PATELLA ¿JUST FELL OFF¿ AND WAS REVISED. THE LOOSENED INTERFACE OF THE PATELLAR BUTTON WAS NOT PROVIDED. THE PATIENT WAS REVISED WITH A COMPETITOR REVISION KNEE. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2015; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11673315 ↗
• InjuryMar 23, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT RECEIVED A RIGHT KNEE PRIMARY ATTUNE TO TREAT END-STAGE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A RIGHT KNEE REVISION TO TREAT PAIN SECONDARY TO GROSS LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, A SYNOVECTOMY WAS PERFORMED. THE TIBIAL TRAY WAS GROSSLY LOOSE AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND REVISED. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED. THE PATELLA WAS WELL-FIXED AND RETAINED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE FEMORAL COMPONENT OR TIBIAL INSERT REVISED TO ACCOMMODATE A COMPETITOR REVISION KNEE SYSTEM. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2017, DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11558834 ↗
• InjuryMar 11, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT RECEIVED A LEFT ATTUNE TOTAL KNEE TO TREAT OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO ADDRESS PAIN AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THERE WAS NOTED TO BE SCAR REMOVAL. THE SURGEON ALSO NOTED MINIMAL BONE LOSS WITH REMOVAL OF THE WELL-FIXED FEMORAL COMPONENT. THE TIBIAL INSERT, TIBIAL TRAY, AND FEMORAL COMPONENT WERE REVISED. THE PATELLAR COMPONENT WAS RETAINED. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS AND CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2017; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Adhesion(s); Pain

  MAUDE report 11463686 ↗
• InjuryMar 9, 2021Use of Device Problem; Use of Device Problem

  MEDICAL RECORDS AD (B)(6) 2021 WERE REVIEWED. ON (B)(6) 2014, THE PATIENT HAD A LEFT TOTAL KNEE REPLACEMENT TO ADDRESS DEGENERATIVE JOINT DISEASE. DEPUY COMPONENTS INCLUDING DEPUY PATELLA AND DEPUY CEMENT X2 WAS UTILIZED DURING THIS PROCEDURE. ON (B)(6) 2016, THE PATIENT HAD AN EXPLANT LEFT TOTAL KNEE TO ADDRESS PAIN AND INFECTION. THE PREOPERATIVE SUMMARY INCLUDED THAT THE TIBIA TRAY IS IN SOME VARUS AND WAS ¿OBVIOUSLY LOOSE¿, NO INTERFACE PROVIDED. THE FEMORAL COMPONENT WAS NOT LOOSE, BUT WAS REVISED. NO MENTION OF REVISING THE PATELLA. THERE WAS NO MENTION OF THE MANUFACTURER OF THE SPACERS IMPLANTED DURING THIS PROCEDURE. DOI: (B)(6) 2014 DOR: (B)(6) 2016 (LEFT KNEE).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 11447812 ↗
• InjuryJan 4, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS ASEPTIC LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2015. DOR: (B)(6) 2020. RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 11112905 ↗
• InjurySep 17, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT RECEIVED A LEFT PRIMARY ATTUNE TO TREAT PAIN SECONDARY TO OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND UNKNOWN CEMENT WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE ATTUNE REVISION TO TREAT PAIN AND RECURRENT SWELLING SECONDARY TO A LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON EXCISED PERIARTICULAR SCAR TISSUE. THE TIBIAL TRAY WAS GROSSLY LOOSE AT AN UNKNOWN INTERFACE AND REMOVED. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED. THE PATELLA WAS WELL-FIXED AND RETAINED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE EXPLANTED TIBIAL INSERT. THE PATIENT WAS REVISED WITH A DEPUY TC3 REVISION CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2016, DOR: (B)(6) 2017, LEFT KNEE.

  Patient problems: Adhesion(s); Edema; No Code Available; Pain

  MAUDE report 10547912 ↗
• InjuryAug 24, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL LEFT KNEE AND LOOSENING OF THE TIBIA AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2018, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10442583 ↗
• InjuryJun 1, 2020Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  ATTUNE KNEE CLAIM RECORD RECEIVED. CLAIM RECORD ALLEGES INJURIES, PAIN, ANGUISH, DISFIGUREMENT AND PHYSICAL IMPAIRMENT. DOI: (B)(6) 2016. DOR: (B)(6) 2018. RIGHT KNEE.

  Patient problems: Deformity/ Disfigurement; Injury; No Code Available; Pain

  MAUDE report 10104194 ↗
• InjuryJun 1, 2020Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  ATTUNE KNEE CLAIM RECORD RECEIVED. CLAIM RECORD ALLEGES INJURIES, PAIN, ANGUISH, DISFIGUREMENT AND PHYSICAL IMPAIRMENT. DOI: (B)(6) 2016. DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Deformity/ Disfigurement; Injury; No Code Available; Pain

  MAUDE report 10104177 ↗
• InjuryMay 28, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT HAD KNEE REVISION FOR PAIN. PERIOPERATIVE FINDINGS WERE LOOSE TIBIA COMPONENT. CULTURES WERE TAKEN AND REVEALED NO INFECTION. PATIENT THEN HAD KNEE REVISION AND NEW COMPONENTS WERE IMPLANTED. THERE WAS NO ADVERSE EVENTS DURING THE CASE. IT WAS UNKNOWN WHAT CEMENT WAS USED. THERE IS NOTHING MORE TO REPORT OR OBTAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 10096829 ↗
• InjuryDec 19, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2017, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO DEGENERATIVE JOINT DISEASE AND VALGUS. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND SMARTSET BONE CEMENT X 2. ON (B)(6) 2019, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT, LACK OF MOTION, FUSIONS, AND PAIN. THE SURGEON REPORTED THE TIBIA HAD BONE THAT HAD GROWN UP AROUND THE TIBIAL TRAY AS IF THE BODY WAS TRYING TO STABILIZE A LOOSE IMPLANT. THE TIBIAL TRAY WAS EASILY REMOVED AND HAD NO CEMENT ADHERENT AT THE TRAY TO CEMENT INTERFACE. THE CEMENT WAS WELL-FIXED TO THE BONE. THE FEMORAL COMPONENT WAS REMOVED WITH MINIMAL BONE LOSS. THE SURGEON INDICATED THE PATELLA WAS REVISED. THE PATIENT WAS IMPLANTED WITH DEPUY REVISION KNEE SYSTEM. COMPETITOR¿S CEMENT WAS UTILIZED, AND THERE WERE NO COMPLICATIONS REPORTED. DOI: (B)(6) 2017. DOR: (B)(6) 2019, (LT KNEE).

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 9496793 ↗
• InjuryDec 19, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO TIBIAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE FEMORAL COMPONENT WAS WELL FIXED AND TOOK SOME TIME GETTING IT OUT. POLY APPEARED TO HAVE NO ABNORMAL WEAR. DEPUY CEMENT WAS USED. DOI: (B)(6) 2015; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9495438 ↗
• InjuryDec 13, 2019Unintended Movement; Loosening of Implant Not Related to Bone-Ingrowth; Unintended Movement; Loosening of Implant Not Related to Bone-Ingrowth

  ATTUNE KNEE CLAIM LETTER RECEIVED. CLAIM LETTER ALLEGED PERSONAL INJURY AND DEFECTIVE ATTUNE KNEE DEVICE. DOI: (B)(6) 2016. DOR: NOT REPORTED UNKNOWN AFFECTED SIDE.

  Patient problems: Injury; No Code Available; Pain

  MAUDE report 9468682 ↗
• InjuryDec 3, 2019Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT UNDERWENT A SECOND RIGHT KNEE REVISION DUE TO INFECTION. THE SURGEON REMOVED ALL COMPONENTS AND PLACED AN ANTIBIOTIC SPACER. THE SURGEON NOTED OSTEOMYELITIS OF THE FEMUR AND TIBIA AS WELL AS A LOOSE TIBIAL TRAY AND FEMORAL COMPONENT AT AN UNKNOWN INTERFACE. COMPETITOR CEMENT WAS USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2014; (TIBIAL TRAY, FEMORAL AND PATELLAR COMPONENT); DOI: (B)(6) 2014; (TIBIAL INSERT); DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9401449 ↗
• InjuryNov 19, 2019Migration; Migration

  THE PATIENT WAS REVISED DUE TO PAIN SECONDARY TO TIBIAL SUBSIDENCE AND TO ADDRESS LOOSENING OF THE TIBIAL AND PATELLA COMPONENT AT THE BONE TO CEMENT INTERFACE. COMPETITOR CEMENT WAS USED. DOI: (B)(6) 2016, DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9341119 ↗
• InjuryNov 18, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2015, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY DUE TO DEGENERATIVE ARTHRITIS. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND SMARTSET BONE CEMENT X 2. ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO LOOSENING, SWELLING, AND PAIN. THE SURGEON REPORTED THE TIBIAL COMPONENT WAS REMOVED EASILY BY HAND, AND THAT IT HAD COMPLETELY DE-BONDED FROM ITS UNDERLINING CEMENT MANTLE. THE SURGEON DID NOT COMMENT ON THE PATELLAR NOR FEMORAL COMPONENTS AND NEITHER WERE REVISED. THE PATIENT WAS IMPLANTED WITH ATTUNE TIBIAL COMPONENT SYSTEM AND SMARTSET BONE CEMENT X 1. THERE WERE NO COMPLICATIONS REPORTED WITH THE PROCEDURE. DOI: (B)(6) 2015; DOR: (B)(6) 2019; (RT KNEE).

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 9336024 ↗
• InjuryNov 7, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 15 OCTOBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2017, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY DUE TO DEGENERATIVE ARTHRITIS. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND COMPETITOR BONE CEMENT. ON (B)(6) 2018, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO STIFFNESS, FLEXION INSTABILITY, AND PAIN. THE SURGEON INDICATED THE WHEN THE TIBIAL COMPONENT WAS DIS-IMPACTED, IT DE-BONDED FROM THE CEMENT. THE FEMORAL COMPONENT WAS REVISED. THE PATELLAR COMPONENT WAS NOT REVISED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2017; DOR: (B)(6) 2018; (RT KNEE).

  Patient problems: No Code Available; Pain

  MAUDE report 9290796 ↗
• InjuryOct 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. IMPLANTS REMOVED AND ANTIBIOTIC SPACER WAS IMPLANTED. DOI: UNKNOWN. DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9224412 ↗
• InjuryOct 18, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 30 SEPTEMBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2016, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO END STAGE DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND SMARTSET BONE CEMENT X 3. ON (B)(6) 2019, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO LOOSENING AND PAIN. THE SURGEON INDICATED WITH GENTLE TAPPING THE TIBIAL TRAY WAS REMOVED AND SHOWED NO EVIDENCE OF CEMENT BONDING. HE REPORTED THE FEMUR WAS A LITTLE INTERNALLY ROTATED, SO WAS REVISED. THE SURGEON NOTED PATELLAR MALTRACKING, SO WAS REVISED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2016; DOR: (B)(6) 2019; (LT KNEE).

  Patient problems: No Code Available; Pain

  MAUDE report 9209660 ↗
• InjuryOct 15, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 20 SEPTEMBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2018, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND SMARTSET BONE CEMENT X 2. ON (B)(6) 2018, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT, INSTABILITY, LAXITY, AND SWELLING. THE SURGEON INDICATED THE TIBIAL COMPONENT WAS LOOSE AND THERE WAS NO CEMENT ON THE TIBIAL COMPONENT BACKSIDE. THE SURGEON REPORTED THE FEMORAL COMPONENT WAS WELL-FIXED THOUGH WAS REVISED. HE NOTED THE PATELLA HAD CENTRAL TRACKING AND IT WAS NOT REVISED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2018; DOR: (B)(6) 2018; (LT KNEE).

  Patient problems: Edema; No Code Available

  MAUDE report 9194681 ↗
• InjuryOct 15, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  UPDATE: MEDICAL RECORDS RECEIVED AD 16 OCT 2019 WERE REVIEWED ON 07 NOV 2019 FOR MDR REPORTABILITY. OFFICE VISIT NOTES (B)(6) 2015 INDICATE THE PATIENT IS EXPERIENCING SOME ANGIOEDEMA OF THE FACE AND LIPS, HE TOOK SOME BENADRYL AND WAS NOTED TO BE IMPROVING. THERE IS NO INDICATION THAT THE DEPUY IMPLANTS WOULD HAVE CAUSED OR CONTRIBUTED TO THIS REACTION. OFFICE VISIT NOTES (B)(6) 2016 INDICATE THE PATIENT IS EXPERIENCING CLICKING IN HIS KNEE. OFFICE VISIT NOTES (B)(6) 2016 INDICATE THE PATIENT IS EXPERIENCING RECURRENT SWELLING, STIFFNESS, PAIN AND OCCASIONAL INSTABILITY. X-RAYS FROM THIS SAME VISIT INTERPRET THE FOLLOWING: LOOSENING OF THE TIBIAL COMPONENT. FEMORAL COMPONENT IS INTACT. OFFICE VISIT NOTES (B)(6) 2016 INDICATE THE PATIENT IS ALSO EXPERIENCING, IN ADDITION TO WHAT HAS BEEN PREVIOUSLY DOCUMENTED, MILD PATELLA-FEMORAL CREPITUS AND EFFUSION NOTED. OFFICE VISIT NOTES (B)(6) 2017 INDICATE THE PATIENT IS STATUS POST REVISION AND DOING VERY WELL. ASPIRATION OF EFFUSION WAS PERFORMED, NO INDICATION OF ORIGIN OR OUTCOME OF EFFUSION FLUID. FOLLOWING VISIT (B)(6) 2017 INDICATES NO FURTHER CONCERNS AND IT IS INDICATED THE KNEE IS HEALING AND FUNCTIONING WELL. OFFICE VISIT NOTES

  Patient problems: Edema; Joint Disorder; Muscular Rigidity; No Code Available; Pain

  MAUDE report 9191999 ↗
• InjurySep 25, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS RECEIVED AD 17 JUNE 2019. THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO PAIN AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THREE DEPUY CEMENT PRODUCTS WERE USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2016; DOR: 7/6/2018, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9119535 ↗
• InjuryAug 23, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO PAIN AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. TWO DEPUY CEMENT PRODUCTS WERE USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2017; DOR: (B)(6) 2018, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8925745 ↗