EXACTECHGPS I00020Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862252821), received between May 21, 2019 and Nov 15, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Computer Operating System Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K100742, K152764); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, A ¿STRANGE¿ PHENOMENON WITH GPS UNIT SERIAL (B)(6) OCCURRED WHERE NEITHER THE REPRESENTATIVE NOR THE SALES MANAGER COULD FIND AN EXPLANATION. THE SURGEON FOUND A DISCREPANCY BETWEEN THE PLANNED CENTRAL HOLE / PEG POSITION, AND WHAT WAS DETERMINED INTRA-OPERATIVELY. THE GPS UNIT SEEMS TO HAVE HAD AN ISSUE WITH ACCURACY. THEY WENT BACK TO THE ACQUISITION SCREEN AFTER THE SURGEON SAID HE PERFORATED THE FAULT AND WAS QUESTIONING THE ACCURACY OF THE PILOT TIP AND THAT IT CAUSED THE ERROR, SO THE REP HAD THE SURGEON GO BACK AND PICK A FEW POINTS TO SHOW THEY WERE GOOD. THE SURGEON WAS STILL CONVINCED THEY WERE OFF AND HE RE-DID THE CENTRAL PEG WHERE HE FELT WAS BETTER. FROM THE REPS MEMORY, THE SURGEON USED THE SCANS AND VISUALIZATION TO DETERMINE A REAMING POSITION THAT BETTER FIT THE IMPLANT IN THE GLENOID TO AVOID PERFORATION OF THE PEG. AFTER REPOSITIONING THE REAMER TO A POSITION, HE FELT BETTER MATCHED WHAT WAS REQUIRED, THE BASEPLATE WAS INSERTED, AND THE SURGEON WAS HAPPY WITH THE FINAL OUTCOME. THE PERFORATION OF THE BONE WAS RESOLVED BY REPOSITIONING THE K-WIRE/IMPLANT TO A BETTER POSITION, TO POSITION THE IMPLANT INSIDE THE GLE

  Patient problems: Bone Fracture(s)

  MAUDE report 18144001 ↗
• InjuryMay 21, 2019Contamination /Decontamination Problem; Computer Operating System Problem

  DURING THE SECOND GPS+ CASE OF THE DAY, DR. (B)(6) EXPERIENCED THE FOLLOWING: TRACKER ACQUISITION WAS A PROBLEM. INTERESTINGLY THE F TRACKER. WOULD NOT COMPLETE ACQUISITION THAT LED TO DECISION TO REBOOT BECAUSE IT WOULD NOT RE-ACQUIRE. ENDED UP REBOOTING COMPUTER AND REMOVING BATTERIES, RE-ACQUIRING TRACKERS. HIP CENTER - ACQUIRED WITHOUT DIFFICULTY. IM GUIDED - PINNING WITHOUT DIFFICULTY. G - SLOT GUIDE - READ 6 DEGREES VARUS. HAD MORE DIFFICULTY THAT USUALLY ACQUIRING ACCURACY. THE PATIENT IS SHORT - 4¿ 11 ¿ AND DEPTH OF RESECTION SEEMED REASONABLE. THE SPACER BLOCKS CONFIRMED THAT THE CUT WAS WAY OFF. CONVERTED TO CC FEMUR AND OLD SCHOOL - ALIGNMENT ROD AND BOVIE CORD - FIXED THE SOFT TISSUE BALANCE AND PROBLEM. AFTER DISCUSSION WITH THE DOCTOR, IT WAS DETERMINED THAT THE LIKELY CAUSE OF THE EVENT WAS THE "SMUDGE" ON THE CAMERA OF THE GPS UNIT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8627240 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100742, K152764. One submission often covers many models, so check the product and lot details in each record.

• Z-1149-2020 · Sep 22, 2019 · Terminated
  Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002