ATTUNE 2545-00-945Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295135227), received between Feb 13, 2018 and Apr 5, 2024 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2024Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT THE ATTUNE INSTRUMENTS ARE BROKEN/WORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19049935 ↗
• MalfunctionMay 26, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO DESCRIPTION OF THE DAMAGE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17009872 ↗
• MalfunctionMay 26, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO DESCRIPTION OF THE DAMAGE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17009850 ↗
• MalfunctionJan 31, 2023Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  EMAIL RECEIVED FROM CSSD TECH WITH A LIST OF BROKEN CONSIGNMENT ATTUNE INSTRUMENTS. EMAIL CONTAINED ONLY THE REF CODES FOR THE SHIMS. THERE WAS NO OTHER DETAILS PROVIDED. NO LOT CODES WERE ALSO PROVIDED. REP ONSITE ON TUESDAY AND WILL CHASE UP LOT CODES. NO DESCRIPTION OF DAMAGE OR HOW THE DAMAGE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16275109 ↗
• MalfunctionJan 31, 2023Break; Break

  EMAIL RECEIVED FROM CSSD TECH WITH A LIST OF BROKEN CONSIGNMENT ATTUNE INSTRUMENTS. EMAIL CONTAINED ONLY THE REF CODES FOR THE SHIMS. THERE WAS NO OTHER DETAILS PROVIDED. NO LOT CODES WERE ALSO PROVIDED. REP ONSITE ON TUESDAY AND WILL CHASE UP LOT CODES. NO DESCRIPTION OF DAMAGE OR HOW THE DAMAGE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16274961 ↗
• MalfunctionDec 3, 2021Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  ATTUNE SHIM HAS CRACKED AROUND THE METAL INSERT AREA. ALSO ON TWO OF THE SHIMS THE METAL INSERT HAS STATED TO COME OUT OF SHIM BODY. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12923699 ↗
• MalfunctionNov 17, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  METAL RING IS NOT SITTING FLUSH WITH THE PLASTIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12828488 ↗
• MalfunctionApr 7, 2021Break; Break

  IT WAS REPORTED THAT THE ATTUNE SHIMS AND EXCEL T-HANDLE WAS BROKEN. NO PATIENT CONSEQUENCES OR SURGICAL DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11632017 ↗
• MalfunctionJan 13, 2021Break; Break

  BROKEN INSTRUMENTS SUSTAINED OVER THE CHRISTMAS PERIOD. EMAIL PROVIDES DETAILS OF WHAT INSTRUMENTS ARE BROKEN WITH THE RELEVANT BATCH NUMBERS. THE EMAIL DOES NOT PROVIDE INFORMATION ON WHERE OR HOW THESE INSTRUMENTS BROKE AND IF DEBRIS WAS GENERATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11166791 ↗
• MalfunctionAug 5, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent

  UNKNOWN SURGEON. BROKEN AND WORN ATTUNE INSTRUMENTS REPORTED BY (B)(6) POST SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10366842 ↗
• MalfunctionMar 24, 2020Break; Break

  BROKEN 4 X ATTUNE SHIMS AND EXCEL T HANDLE REPORTED BY CSSD STAFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9871126 ↗
• MalfunctionSep 19, 2019Break; Crack; Break; Crack

  TWO BROKEN INSTRUMENTS WERE TAGGED FROM STERILE PROCESSING DEPARTMENT. THE 32MM X 64N BLUE LINER TRIAL WAS USED OVER THE WEEKEND FOR A CUP EXTRACTION. ZIMMER CUP EXTRACTION INSTRUMENT WAS USED AND SCRATCHED/ DAMAGED OUT EDGE OF THE CUP TRIAL. SZ 8 SZ 7 20MM ATTUNE SHIM HAS A SMALL CRACK IN IT AND WAS HANDED TO ME FROM STERILE PROCESSING. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? : UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED? : YES, WERE FRAGMENTS GENERATED? : YES, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? : YES, PATIENT STATUS/ OUTCOME / CONSEQUENCES : NO, 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, (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: No Consequences Or Impact To Patient

  MAUDE report 9086986 ↗
• MalfunctionApr 5, 2019Material Disintegration; No Apparent Adverse Event; Insufficient Device Problem Information; Material Disintegration; No Apparent Adverse Event; Insufficient Device Problem Information

  STERILIZATION REPORTED A FEW DAMAGED ATTUNE INSTRUMENTS THAT REQUIRE REPLACEMENT. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8488255 ↗
• MalfunctionNov 6, 2018Break; Break

  IT WAS REPORTED THAT THE TRIALS WERE BROKEN THROUGH NORMAL USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8042492 ↗
• MalfunctionJul 10, 2018Break; Break

  IT WAS REPORTED THAT INSTRUMENTS WERE BROKEN. DIDN'T IMPACT ANY CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7672973 ↗
• MalfunctionFeb 13, 2018Crack; Crack

  SHIMS HAVE CRACKED AROUND THE METAL INSERT AREA. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7266259 ↗