ATTUNE 1512-14-130Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295475187), received between Aug 16, 2021 and Jul 27, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient contracted MRSA, all implants removed and replaced with antibiotic spacer.DOI: Unknown.DOR: Unknown.Affected Side: Left Knee.

  Patient problems: Unspecified Infection

  MAUDE report 50039235 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ INFECTION, DEVICE AND PROCEDURE (RELATEDNESS), DEVICE RELATED: NO INFORMATION PROVIDED, PROCEDURE RELATED: NO INFORMATION PROVIDED, DATE OF EVENT: 29 DEC 2025, DATE OF IMPLANT: (B)(6) 2025, DATE OF REVISION: (B)(6) 2025, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: DEPUY SYNTHES COMPONENTS REMOVED (FEMORAL AND TIBIAL COMPONENTS).

  Patient problems: Unspecified Infection

  MAUDE report 24200723 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CONTINUES TO SHOW SIGNS OF INFECTION AND WAS BROUGHT TO THE OR FOR BILATERAL KNEE REVISIONS. COMPONENTS WERE REMOVED AND THOROUGH I&DS WERE PERFORMED IN CONJUNCTION WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS, AND PLACEMENT OF NEW COMPONENTS. PATIENT DID HAVE BILATERAL I&DS WITH POLY EXCHANGES ON (B)(6) 2025. AS SUCH, THE INSERTS LISTED ON THIS SUBMISSION WERE FROM THAT DATE. THE RIGHT KNEE SHOWED SIGNIFICANT HETEROTOPIC OSSIFICATION AROUND THE FEMORAL SLEEVE, SUGGESTING INFECTION ON XRAY, SO SURGEON TO CHOSE TO FASHION A STATIC SPACER UTILIZING LPS COMPONENTS TO TREAT THIS SIDE. THE LEFT SIDE APPEARED TO BE DOING BETTER, BUT SINCE HOSPITAL ADMISSION EARLIER THIS WEEK ALSO BEGIN TO SWELL. WHEN CHECKING FIXATION OF THE FEMORAL COMPONENT, THE FEMORAL SLEEVE WAS ABLE TO BE REMOVED WITHOUT SIGNS OF BONY INGROWTH. LACK OF INGROWTH APPROXIMATELY SEVEN (7) WEEKS POST IMPLANTATION SUGGESTS THIS TOO WAS INFECTED. TIBIAL COMPONENT AND STEM WERE LEFT IN PLACE ON THE LEFT SIDE SINCE IT WAS WELL FIXED. NO DELAY NOR PATIENT HARM WAS NOTED. WHILE RESULTS ARE NOT YET AVAILABLE, SURGEON DOES BELIEVE INFECTION WAS STILL PRESENT AT THE TIME OF THIS PROCEDURE. THIS INFEC

  Patient problems: Extraskeletal ossification; Unspecified Infection

  MAUDE report 22159356 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE EMERGENCY ROOM IN (B)(6) WITH BILATERAL INFECTED KNEES FROM AN ACUTE INFECTION IN THE PATIENTS BLOOD. IT AFFECTED BOTH THE KNEES WHICH HAD REV IMPLANTS IN AND BOTH THE SHOULDERS WHICH HAD NO IMPLANTS. PATIENT WAS WASHED OUT AND IMPLANT EXCHANGES TOOK PLACE ON 2 SEPARATE OCCASIONS AT A DIFFERENT FACILITY. DERS WERE SUBMITTED. PATIENT CAME INTO CLINIC FOR FOLLOW UP ON (B)(6) 2025 AND BOTH KNEES APPEARED TO STILL BE INFECTED. CULTURES SHOWED A SENSITIVE STREP. SURGEON ADMITTED THE PATIENT AND BILATERAL KNEE REVISIONS WERE PERFORMED IN A ONE STAGE FASHION TO INCLUDE THOROUGH IRRIGATION AND DEBRIDEMENT AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. THERE WAS NO DELAY NOR PATIENT HARM NOTED. NO ALLEGATIONS WERE MADE AGAINST ANY COMPONENT AS THIS WAS FROM AN ORGANISM IN PATIENT BLOOD THAT AFFECTED MULTIPLE JOINTS IN PATIENT'S BODY. DATE OF IMPLANTATIONS: RIGHT REVISION KNEE WAS (B)(6) 2016. LEFT REVISION KNEE WAS (B)(6) 2023. ON (B)(6) 2025, AN I&D AND INSERT EXCHANGE TOOK PLACE FOR THE LEFT KNEE FOR HEMATOMAS, AND POSSIBLE INFECTION (NOT CONFIRMED AT THAT TIME) AT (B)(6) MEDICAL CENTER. CAPTURED IN (B)(4). AT THE SAME TIME, ON (B)(6) 2025,

  Patient problems: Unspecified Infection

  MAUDE report 21883789 ↗
• InjuryOct 19, 2023Fracture; Fracture

  THE SALES REP HAS THE INFORMATION FROM THE FIELD THAT A FEMORAL STEM BROKE INTO A PATIENT AT THE FEMORAL BOLT CONNECTION. THE PATIENT NEED A FEMORAL REPLACEMENT SCHEDULED FOR (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 17967347 ↗
• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED RIGHT KNEE. REMOVAL OF IMPLANTS AND SPACER PLACEMENT WAS PERFORMED. DOI: UNKNOWN. DOR: (B)(6), 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17612009 ↗
• InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SEPTIC LOOSENING OF FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. SURGEON EXPLANTED FEMUR AND REVISED WITH TEMPORARY SPACER. DOI: (B)(6) 2021; DOR: (B)(6) 2023; AFFECTED SIDE- UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16184655 ↗
• InjuryAug 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. ALL COMPONENTS WERE EXTRACTED AND A TEMPORARY ABX SPACER WAS PLACED. UNKNOWN BONE CEMENT WAS USED. NO SURGICAL DELAY. DOI: (B)(6) 2019, DOR: (B)(6) 2021. RIGHT KNEE.

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

  MAUDE report 12324883 ↗