ATTUNE 2512-14-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295477808), received between Jun 3, 2019 and Feb 2, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT ATTUNE REV CEM STEM TRL14X50 WAS INVOLVED IN AN EVENT DURING A TOTAL KNEE REPLACEMENT SURGERY. THE TRIAL STEM DISENGAGED FROM THE BOSS REAMER INTRAOPERATIVELY AND WAS UNINTENTIONALLY LEFT INSIDE THE PATIENT'S FEMORAL CANAL, ONLY DISCOVERED POSTOPERATIVELY VIA X-RAY. THE PRODUCT IS NOT AN IMPLANT BUT A TRIAL INSTRUMENT FROM A LOAN SET, AND THERE IS NO PLAN FOR REVISION SURGERY TO REMOVE THE RETAINED PART. THE DEVICE IS NOT AVAILABLE FOR RETURN AS IT REMAINS INSIDE THE PATIENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS, HARM, OR SIGNIFICANT SURGICAL DELAY, AND THE PATIENT WAS DISCHARGED IN STABLE CONDITION WITH ONGOING MONITORING BY THE SURGEON.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24232942 ↗
• InjuryMay 22, 2023Entrapment of Device; Improper or Incorrect Procedure or Method; Entrapment of Device; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE 50MM STEM TRIAL CAME OFF WHEN REAMING. THERE WAS NO SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 16977526 ↗
• MalfunctionDec 18, 2019Entrapment of Device; Entrapment of Device

  THERE WAS AN ATTUNE TKR CASE DONE IN MEH 28/11, WITH THE FOLLOWING IMPLANTS USED - THE PREPARATION OF PRIMARY KNEE INSTRUMENTS WAS DONE ACCORDINGLY AND AS PER PLANNED. FEMUR CUTS PROCEEDED AS PER NORMAL, WHEN PROCEEDING TO TIBIA PREPARATION, DR ASKED FOR SHORT CEMENTED TIBIA 14X50MM STEM AND WE GOT THE INSTRUMENTS READY. HE DRILLED FOR THE STEM, THEN ATTACH THE STEM TRIAL TO THE FAT REAMER (FOR THE CONE). JUST WHEN HE WAS ABOUT TO DO THE KEEL PUNCH, THE INSTRUMENT FELL ONTO THE GROUND. HE THEN CHECKED WITH DR WHO DECIDED TO PREPARE THE KEEL AS PER PRIMARY TRAY. UPON PREPARING AS PER PRIMARY TRAY, HE FOLLOWED THROUGH THE TRIAL WITH THE PRIMARY TRAY TRIAL CONSTRUCT AND DECIDED ON THE IMPLANTS TO BE USED. DESPITE NOT TRIALLING WITH THE STEM, DR ASKED FOR THE STEM IMPLANT AND DECIDED TO IMPLANT WITH IT AS THE PREPARATION WAS ALREADY MADE. WHILE CEMENTING AND IMPLANTING THE TIBIA, HE EXPERIENCED SOME RESISTANCE AND MANAGED TO IMPACT AND IMPLANT THE TIBIA WITH STEM SUCCESSFULLY. UPON CLOSURE, OUR REPS CLEARED THE INSTRUMENTS WHICH WERE ALL LEFT IN THE BASIN BY THE OT SCRUB NURSE AND REALISED THE STEM TRIAL WHICH WAS ORIGINALLY TIGHTLY SCREWED ONTO THE FAT CONICAL REAMER WAS MISSING AND A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9491253 ↗
• MalfunctionJun 3, 2019Entrapment of Device; Device-Device Incompatibility; Entrapment of Device; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2019 VIA TKA BY USING ATTUNE CR FEMORAL COMPONENT AND STEMMABLE TIBIA TRAY. AND IT WAS REVEALED BY POST-OPERATIVE X-RAY THAT THE TRIAL STEM WAS REMAINED AT THE DISTAL END OF THE TIBIAL IMPLANT. AS A RESULT OF CONFIRMATION OF THE INSTRUMENT USED AFTER THE SURGERY, IT WAS FOUND THAT THE TRIAL STEM WAS DETACHED FROM THE DISTAL PORTION OF THE REAMER WHICH WAS ATTACHED IT. THUS, THE REMOVAL SURGERY WAS SCHEDULED TO BE PERFORMED ON (B)(6) 2019 BY EXPLANTING THE TRIAL STEM FROM THE PATIENT RIGHT KNEE JOINT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8662616 ↗