NA 3312-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 258 adverse event reports that list this exact device (DI 10603295168614), received between Aug 10, 2017 and Sep 22, 2026 — classified as 4 deaths, 246 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (90 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 258 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Chemical Problem

  It was reported that during arthroplasty, mixing of the two cement components resulted in a non-homogeneous mass unsuitable for implantation. Therefore, an alternative cement was used, resulting in a 15-minute surgical delay.

  Patient problems: Insufficient Information

  MAUDE report 50852065 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENTS RECEIVED FOR IT BAND TENDINITIS DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: POSSIBLY. DATE OF EVENT: 26/NOV/2024. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: IRRIGATION & DEBRIDEMENT. DEPUY SYNTHES PRODUCT USED: CATALOG ID: 151820032. LOT ID: 3802592. COMPONENT TYPE: PATELLAR. DESCRIPTION: ATTUNE MEDIAL DOME PAT 32MM. CATALOG ID: 151820308. LOT ID: JP9042. COMPONENT TYPE: INSERT. DESCRIPTION: ATTUNE LEFT MEDIAL STABILIZED INSERT SIZE 3 8MM. CATALOG ID: 150400103. LOT ID: 8093073. COMPONENT TYPE: FEMORAL. DESCRIPTION: ATTUNE C/RET FEM LT SZ 3 CEMENTED. CATALOG ID: 150670003. LOT ID: 9854210. COMPONENT TYPE: TIBIAL. DESCRIPTION: ATTUNE FB CEMENTED TIBIAL BASE SIZE 3. CATALOG ID: 249095000. LOT ID: M0476R. COMPONENT TYPE: PIN. DESCRIPTION: AMK FIXATION PINS 1/8 DIA X 3. CATALOG ID: 950502303. LOT ID: M1312Z. COMPONENT TYPE: ACC. DESCRIPTION: SIGMA LCS HIGH PERFORMANCE. STERILE THREADED HEADED PINS. CATALOG ID: 3312040. LOT ID: 3807417. COMPONENT TYPE: CEMENT. DESCRIPTION: SMART SET CMW 1 40G.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 20903554 ↗
• InjuryNov 20, 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: OTHER SURGICAL SITE/DELAYED WOUND HEALING. ON 08/08/2024, MEDICAL RECORDS NOTED, THAT THE PATIENT IS NOW 6 WEEKS OUT FROM RIGHT KNEE. CLINICAL IMPRESSION IS THAT THE PATIENT IS DOING WELL. IT WAS NOTED, THAT THE PATIENT HAS A LOT OF ADIPOSE TISSUE BELOW THEIR KNEE. 10/25/2024, MEDICAL RECORDS NOTED, THE PATIENT¿S CHIEF COMPLAINT IS WOUND CARE. FOLLOW-UP STATUS: POST KNEE ARTHROPLASTY. THE PATIENT IS ON ANTIBIOTICS, THE PATIENT HAS THREE, AT LEAST THREE POCKETS IN THE WOUND AND ONE IS DRAINING PUS. THE PATIENT HAD A DEBRIDEMENT WITH SCALPEL IN THE OFFICE. 10/24/2024, MEDICAL RECORDS NOTED, THE PATIENT IS HAVING A FOLLOW-UP RIGHT KNEE WOUND. PHYSICAL EXAMINATION NOTES, THERE ARE TWO NECROTIC AREAS AT THE DISTAL PORTION OF THEIR INCISION. THE PLAN IS FOR THE PATIENT TO HAVE DEBRIDEMENT AND WOUND VAC PLACEMENT. 11/06/2024, MEDICAL RECORDS NOTED, THE PATIENT IS HAVING A FOLLOW-UP RIGHT KNEE SUPERFICIAL AND DRAINAGE. STATUS POST SUPERFICIAL I AND D OF THE RIGHT KNEE ALONG WITH WOUND VAC PLACEMENT, DOING WELL.

  Patient problems: Fluid Discharge; Impaired Healing; Necrosis; Purulent Discharge

  MAUDE report 20733260 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6) STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR: OTHER SURGICAL SITE / DELAYED WOUND HEALING ON (B)(6) 2024, MEDICAL RECORDS NOTE THAT THE PATIENT IS NOW 6 WEEKS OUT FROM RIGHT KNEE. CLINICAL IMPRESSION IS THAT THE PATIENT IS DOING WELL. IT WAS NOTED THAT THE PATIENT HAS A LOT OF ADIPOSE TISSUE BELOW THEIR KNEE. (B)(6) 2024 MEDICAL RECORDS NOT THE PATIENT¿S CHIEF COMPLAINT IS WOUND CARE, FOLLOW-UP STATUS POST KNEE ARTHROPLASTY. THE PATIENT IS ON ANTIBIOTICS, THE PATIENT HAS THREE AT LEAST THREE POCKETS IN THE WOUND AND ONE IS DRAINING PUS. THE PATIENT HAD A DEBRIDEMENT WITH SCALPEL IN THE OFFICE. (B)(6) 2024 MEDICAL RECORDS NOTE THE PATIENT IS HAVING A FOLLOW-UP RIGHT KNEE WOUND. PHYSICAL EXAMINATION NOTES THERE ARE TWO NECROTIC AREAS AT THE DISTAL PORTION OF THEIR INCISION. THE PLAN IS FOR THE PATIENT TO HAVE DEBRIDEMENT AND WOUND VAC PLACEMENT. (B)(6) 2024 MEDICAL RECORDS NOTE THE PATIENT IS HAVING A FOLLOW-UP RIGHT KNEE SUPERFICIAL AND DRAINAGE. STATUS POST SUPERFICIAL I AND D OF THE RIGHT KNEE ALONG WITH WOUND VAC PLACEMENT, DOING WELL.

  Patient problems: Fluid Discharge; Impaired Healing; Necrosis; Purulent Discharge

  MAUDE report 20733159 ↗
• InjuryNov 18, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMUR/TIBIA. THE LOOSENING INTERFACE WAS BONE/CEMENT. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20707266 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OPERATIVE NOTES RECEIVED. THE PATIENT UNDERWENT A REVISION OF HER RIGHT KNEE ON (B)(6) 2024 DUE TO CHRONIC INFECTION OVER THE PAST 6 MONTHS CAUSING PAIN AND SWELLING. RADIOGRAPHIC CHANGES SHOW RESORPTIVE CHANGE UNDER THE TIBIA. INTRAOPERATIVELY, SYNOVITIS WAS FOUND AND A BAKER CYST WAS IDENTIFIED THAT HAD BEEN INFECTED. THERE WAS ALSO A CYST SOMEWHAT IN THE LATERAL GUTTER WITH INFECTED TYPE TISSUE WHICH WAS DEBRIDED. THE ENTIRE PROSTHESIS WAS REMOVED AND AN ANTIBIOTIC LOADED SPACER WAS PLACED.

  Patient problems: Ambulation or Postural Difficulties; Cyst(s); Pain; Swelling/ Edema; Synovitis; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20556488 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OPERATIVE NOTES RECEIVED. THE PATIENT UNDERWENT A REVISION OF HER RIGHT KNEE ON (B)(6) 2024 DUE TO CHRONIC INFECTION OVER THE PAST 6 MONTHS CAUSING PAIN AND SWELLING. RADIOGRAPHIC CHANGES SHOW RESORPTIVE CHANGE UNDER THE TIBIA. INTRAOPERATIVELY, SYNOVITIS WAS FOUND AND A BAKER CYST WAS IDENTIFIED THAT HAD BEEN INFECTED. THERE WAS ALSO A CYST SOMEWHAT IN THE LATERAL GUTTER WITH INFECTED TYPE TISSUE WHICH WAS DEBRIDED. THE ENTIRE PROSTHESIS WAS REMOVED AND AN ANTIBIOTIC LOADED SPACER WAS PLACED.

  Patient problems: Ambulation or Postural Difficulties; Cyst(s); Pain; Swelling/ Edema; Synovitis; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20556339 ↗
• InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: ON (B)(6) 2024, THE PATIENT HAD A VISIT WITH THE PHYSICIAN ASSISTANT 5 MONTHS OUT FROM RECEIVING BILATERAL KNEE REPLACEMENTS. THE PATIENT¿S RIGHT KNEE IS NOW PAINFUL AND DOESN¿T FEEL LIKE IT IS IMPROVING. A LOT OF SYNOVITIS, THICKENED SYNOVIUM AND FLUID IN THE KNEE WAS IDENTIFIED. ON (B)(6) 2024, THE PATIENT RETURNS TO THE SURGEON. ON XRAY THERE IS RESORPTION IN TIBIA ZONE 1 AND THE POSTERIOR FLANGE OF THE FEMUR. THE SURGEON SUSPECTS A CHRONIC LOW-GRADE INFECTION. HE PLANS TO EITHER PERFORM A 1-STAGE REVISION OR EXPLANT WITH A TEMPORARY ANTIBIOTIC SPACER DEPENDENT ON WHAT THE CULTURES GROW WITHIN THE NEXT COUPLE WEEKS.

  Patient problems: Fluid Discharge; Pain; Synovitis; Unspecified Infection

  MAUDE report 20421282 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(4). STUDY ID: DOTS A CLINICAL STUDY REPORTED A CLINICAL ADVERSE EVENT ON (B)(6) 2024, FOR A VASCULAR - PULMONARY EMBOLISM (PE). DATE OF IMPLANT IS UNKNOWN.

  Patient problems: Pulmonary Embolism

  MAUDE report 20280877 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR: PE. DEVICE (RELATEDNESS): DEFINITELY NOT. PROCEDURE (RELATEDNESS): POSSIBLY. DATE OF EVENT: 28/AUG/2024. DATE OF IMPLANT: INFORMATION NOT PROVIDED. DATE OF REVISION: INFORMATION NOT PROVIDED. DEVICE LOCATION: INFORMATION NOT PROVIDED. TREATMENT/IMPACT: PE.

  Patient problems: Pulmonary Embolism

  MAUDE report 20278584 ↗
• 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: 08/28/2024 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 20256211 ↗
• 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: 08/28/2024 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 20256179 ↗
• 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 20256051 ↗
• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. CLINICAL ADVERSE EVENTS RECEIVED FOR BONE FRACTURE - FEMORAL. DEVICE AND PROCEDURE(RELATEDNESS). DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: REMOTE POSSIBILITY. DATE OF EVENT: 29/JUL/2024. DATE OF IMPLANT: INFORMATION NOT PROVIDED. DATE OF REVISION: INFORMATION NOT PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: INFORMATION NOT PROVIDED. FIELD CHANGED: DATE OF INITIAL ONSET. INITIAL VALUE: UPDATED VALUE: 29/JUL/2024. ADDITIONAL EVENT INFORMATION. UPDATE: MEDICAL RECORDS RECEIVED ON AD 13 AUGUST 2024 WERE REVIEWED BY A CLINICIAN TO IDENTIFY PATIENT HARMS/PRODUCT ISSUES. IN (B)(6) 2023, FEMALE PATIENT FELL AND DEHISCED HER WOUND 1 MONTH AFTER A RIGHT TKA. SHE WAS TREATED WITH AN I& D AND LONG-TERM IV ANTIBIOTICS FOR A SUBSEQUENT INFECTION SECONDARY TO THE DEHISCENCE. THE OPERATIVE NOTE INDICATES THE PATIENT RECEIVED AN ASPIRATION DURING THIS TREATMENT THAT CONFIRMED A STAPH INFECTION. THE PATIENT HAD WOUND HEALING ISSUES AND A BOIL AT THE SITE OF THE DEHISCENCE. THE TREATMENT WAS ULTIMATELY INEFFECTIVE, AND THE PATIENT WAS REFERRED FOR A TWO-STAGE REVISION OF THE RIGHT KNEE. THE ONLY KNOWN DEPUY PRODUCT ASSOCIATED WITH THE INFECTION IS DE

  Patient problems: Abscess; Adhesion(s); Fall; Impaired Healing; Loss of Range of Motion; Pain; Swelling/ Edema; Synovitis; Unspecified Infection; Wound Dehiscence

  MAUDE report 20076622 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DOTS. CLINICAL ADVERSE EVENTS RECEIVED FOR INFECTION - DEEP. DEVICE AND PROCEDURE(RELATEDNESS). DEVICE RELATED: REMOTE POSSIBILITY. PROCEDURE RELATED: PROBABLY. DATE OF IMPLANT: (B)(6) 2024. DATE OF REVISION: (B)(6) 2024. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: REVISION.

  Patient problems: Adhesion(s); Impaired Healing; Pain; Post Operative Wound Infection; Unspecified Infection

  MAUDE report 20055725 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DOTS. CLINICAL ADVERSE EVENTS RECEIVED FOR INFECTION - DEEP. DEVICE AND PROCEDURE(RELATEDNESS). DEVICE RELATED: REMOTE POSSIBILITY. PROCEDURE RELATED: PROBABLY. DATE OF IMPLANT: (B)(6) 2024. DATE OF REVISION: (B)(6) 2024. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: REVISION.

  Patient problems: Adhesion(s); Impaired Healing; Pain; Post Operative Wound Infection; Unspecified Infection

  MAUDE report 20052167 ↗
• InjuryJul 10, 2024Loss 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

  SUBJECT ID: (B)(6). STUDY NO: DOTS. ASSOCIATED STUDY: ROTATING PLATFORM, ROTATING PLATFORM DATE OF EVALUATION: (B)(6) 2024. DATE OF ONSET: (B)(6) 2024 OPERATIVE SIDE: RIGHT. DIAGNOSIS: CHRONIC INFECTION. ADVERSE EVENT: INFECTION - DEEP. SPECIFY: COUNTRY: US. SERIOUS: YES. DEVICE RELATED: REMOTE POSSIBILITY. PROCEDURE RELATED: REMOTE POSSIBILITY. ADDITIONAL EVENT INFORMATION: ON (B)(6) 2021, THE PATIENT WAS NOTED TO HAVE HAD A RIGHT TOTAL KNEE ARTHROPLASTY. ON (B)(6) 2022, THE PATIENT WAS NOTED TO HAVE FALLEN AND SUSTAINED A DISTAL FEMUR FRACTURE AND UNDERWENT ORIF OF THE DISTAL FEMUR FRACTURE. ON (B)(6) 2024 MEDICAL RECORDS NOTE THE PATIENT HAD RIGHT KNEE PAIN, STATUS POST TOTAL KNEE REPLACEMENT AND SUBSEQUENT ORIF OF DISTAL FEMUR FRACTURE. IT WAS NOTED THAT THE PATIENT CONTINUES TO HAVE INTERMITTENT CELLULITIS SINCE THE ORIF ON (B)(6) 2022. IT WAS NOTE THAT THE PATIENT HAD INTERMITTENT CELLULITIS. THE KNEE HAD BE ASPIRATED (B)(6) 2023, WHICH SHOWED A STAPH EPIDERMIDIS INFECTION. RADIOLOGICAL REPORT NOTES THE PATIENT HAS A RIGHT TOTAL KNEE ARTHROPLASTY WITH SUBSIDENCE AND LOOSENING OF THE FEMORAL COMPONENT. THE RIGHT KNEE WAS NOTED TO HAVE CHRONIC INFECTION.

  Patient problems: Cellulitis; Pain; Unspecified Infection

  MAUDE report 19709639 ↗
• InjuryJun 24, 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 ADHESIONS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT:(B)(6) 2024. DATE OF EVENT:(B)(6) 2024. (LEFT KNEE). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Adhesion(s)

  MAUDE report 19597631 ↗
• InjuryJun 18, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT AT THE DISTAL FLAT & ANTERIOR PART OF FEMORAL COMPONENT. TOTAL KNEE REVISION WAS PERFORMED. THERE WAS NO SURGICAL DELAY AND NO HARM TO PATIENT. DOI: (B)(6), 2019. DOR: (B)(6), 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19564154 ↗
• InjuryJun 18, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT AT THE DISTAL FLAT & ANTERIOR PART OF FEMORAL COMPONENT. TOTAL KNEE REVISION WAS PERFORMED. THERE WAS NO SURGICAL DELAY AND NO HARM TO PATIENT. DOI: (B)(6) 2019. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19564152 ↗
• InjuryJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2024. DATE REVISION: (B)(6) 2024. DATE OF EVENT: 05 JUN 2024. (LEFT HIP). TREATMENT: REVISION; PRODUCTS REVISED UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 19537830 ↗
• InjuryJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2024. DATE REVISION: UNK (B)(6) 2024. DATE OF EVENT: (B)(6) 2024. (LEFT HIP). TREATMENT: REVISION; PRODUCTS REVISED UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 19537824 ↗
• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6) STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR PULMONARY EMBOLISMS. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023 DATE OF EVENT: (B)(6) 2023 (RIGHT KNEE). TREATMENT: ORAL MEDICATION AND CLOT REMOVALS.

  Patient problems: Pulmonary Embolism

  MAUDE report 19464092 ↗
• InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR POSSIBLE INFECTION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2023 DATE OF EVENT: (B)(6) 2024 (LEFT KNEE) TREATMENT: ASPIRATION.

  Patient problems: Unspecified Infection

  MAUDE report 19342409 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR BONE FRACTURE - FEMORAL. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2024 DATE OF REVISION: (B)(6) 2024 DATE OF EVENT: 25 MAR 2024. (RIGHT KNEE). TREATMENT: REVISION; FEMORAL, TIBIAL, AND INSERT WERE REVISED. ADDITIONAL INFORMATION: ON 03/26/2024, THE PATIENT HAD A REVISION RIGHT KNEE PERIPROSTHETIC FEMUR FRACTURE TO A FINN HINGED KNEE PROSTHESIS. THE PATIENT HAD A PREVIOUS ARTHROPLASTY 3 WEEKS PRIOR. PRIOR TO THE CURRENT REVISION SURGERY, THE PATIENT REPORTED HAVING INCREASING PAIN AND DISCOMFORT. ALL COMPONENT USED DURING THIS REVISION SURGERY WERE CEMENTED IN USING DEPUY CEMENT.

  Patient problems: Discomfort; Pain

  MAUDE report 19222129 ↗