NA 03.401.072Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982079824), received between Feb 2, 2017 and Sep 24, 2018 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2018Break; Break

  IT WAS REPORTED THAT DURING A REVISION SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE, THE STEM EXTRACTOR BROKE. THE SURGEON WAS USING THE SLAP HAMMER ATTACHMENT TRYING TO REMOVE AN EPOCA STEM. AFTER MULTIPLE STRIKES THE SCREW BROKE. THERE WAS A SURGICAL DELAY OF APPROXIMATELY SIXTY MINUTES. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES: HUMERAL STEM (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), SLAP HAMMER ATTACHMENT (PART: UNKNOWN, LOT: UNKNOWN, PART: 1). THIS REPORT IS FOR A STEM EXTRACTOR FOR GUIDE BAR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7902792 ↗
• InjurySep 20, 2018Break; Break

  IT WAS REPORTED THAT DURING ARTHROPLASTY ON (B)(6) 2018, THE STEM EXTRACTOR/GUIDE BAR BROKE. THE STEM EXTRACTOR WAS HOOKED TO THE STEM. USING THE SLAP HAMMER AND GUIDE, THE SURGEON REPEATEDLY STRUCK THE SLAP HAMMER AGAINST THE BACK STOP ON THE TOP OF THE GUIDE. AFTER SEVERAL DOZEN STRIKES, THE CONNECTING SCREW ATTACHING THE STEM EXTRACTION DEVICE AND THE SLAP HAMMER BROKE. THE SURGEON REMOVED THE IMPLANT HEAD AND LEFT THE STEM IN BEFORE CLOSING. THE PATIENT WAS REFERRED TO A SPECIALIST. THERE WAS SURGICAL DELAY OF APPROXIMATELY ONE HOUR DUE TO THE EXTRACTION DEVICE BREAKING. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES: STEM/GUIDE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1); SLAP HAMMER (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A STEM EXTRACTOR FOR GUIDE BAR. THIS IS REPORT 1 OF 1 FOR (B)(4 .

  Patient problems: No Code Available

  MAUDE report 7893326 ↗
• MalfunctionAug 11, 2017Break; Break

  DURING THE A REVISION SURGERY ON (B)(6) 2017, THE EPOCA STEM EXTRACTOR'S CONNECTION SCREW DISENGAGED AND BROKE OFF THE EXTRACTION ASSEMBLY. THE STEM EXTRA EXTRACTOR HAD BEEN SECURED TO THE STEM FOR REMOVAL. AFTER REPEATED SLAPPING WITH THE BACK HAMMER THE EPOCA STEM WOULD NOT BACK OUT OF THE BONE AND THE CONNECTING SCREW DISENGAGED AND BROKE IN HALF. IT WAS NOTED THE EPOCA COATING APPEARED TO BE EMBEDDED IN THE HUMERUS. HALF OF THE SCREW BROKE OFF THE OPERATING FIELD AND THE OTHER HALF REMAINED IN THE EPOCA STEM WHICH WAS REMOVED BY HAND. NO FRAGMENTS WERE LEFT BEHIND IN THE PATIENT. ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THE SURGEON USED FLEXIBLE CHISEL AND SAW TO LOOSEN THE STEM FROM THE BONE. A SURGICAL DELAY OF 10 MINUTES WAS NOTED DUE TO THE EXTRA MEDICAL INTERVENTION REQUIRED TO REMOVE THE STEM. THE PATIENT WAS REVISED TO A TORNIER REVERSE SHOULDER (TSA) PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS COMPLAINT INVOLVES 1 DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6788035 ↗
• MalfunctionFeb 6, 2017Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT DURING REVISION SURGERY ON (B)(6) 2017, THE SCREW HEAD OF THE CONNECTING BOLT ON THE STEM EXTRACTOR INSTRUMENT BROKE OFF. THE PATIENT WAS INITIALLY IMPLANTED WITH EPOCA SHOULDER IMPLANTS ON THE RIGHT SIDE ON AN UNKNOWN DATE. DUE TO AN INSUFFICIENT ROTATOR CUFF, THE PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2017 FOR REVISION TO A COMPETITOR'S TOTAL SHOULDER CONSTRUCT. WHILE SURGEON WAS TIGHTENING A BOLT TO THE STEM, THE SCREW HEAD OF THE CONNECTING BOLT ON THE STEM EXTRACTOR BROKE OFF. THE FRAGMENTS WERE EASILY REMOVED. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE USING SURGICAL PLIERS. THE PROCEDURE WAS DELAYED APPROXIMATELY TWO (2) MINUTES DUE TO THIS ISSUE BUT WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: BOLT (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1) THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6306269 ↗
• MalfunctionFeb 2, 2017Break; Break

  DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A REMOVAL SURGERY OF THE EPOCA PROSTHESIS TOOK PLACE ON (B)(6) 2017. THE STEM EXTRACTOR WAS CONNECTED TO THE STEM WITH THE CONNECTING SCREW. DURING REMOVAL OF THE STEM THE CONNECTING SCREW BROKE. THE SURGERY WAS PROLONGED ABOUT 20 MINUTES. NO INFORMATION ABOUT PATIENT CONDITION AND OUTCOME AVAILABLE. THE PROCEDURE WAS A PLANNED EPOCA REMOVAL SURGERY AND AFTER IMPLANTATION OF AN INVERSE PROSTHESIS. THERE WAS NO PATIENT HARM AND THE OUTCOME WAS GOOD. THE EPOCA STEM WAS REMOVED ABOUT 20 MINUTES LATER. ALL BROKEN OFF PIECES WERE REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES 1 PART. CONCOMITANT REPORTED PART: 1X EPOCA STEM (PART AND LOT UNKNOWN) THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6298833 ↗