INSTRUMENT 6278-9-070Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613327221626), received between Oct 16, 2018 and Feb 2, 2026 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Fracture” (10 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 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Fracture

  THE FOLLOWING INFORMATION WAS PROVIDED: SURGEONS WERE REMOVING A REMOVABLE HIP PROSTHESIS (RESTORATION MODULAR), WHICH WAS STUCK AND A PART OF THE BODY/STEM SEPARATOR INSTRUMENT WAS BROKEN WHEN THEY ATTEMPTED TO SEPARATE THE PROXIMAL FROM THE DISTAL PART OF THE PROSTHESIS. THE INSTRUMENT PART BROKE AT THE SAME LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24240518 ↗
• MalfunctionJan 16, 2026Fracture

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO INSTABILITY. A CERAMIC HEAD AND ADM/ MDM POLY INSERT WERE REVISED TO A 28+2 METAL HEAD WITH ANOTHER ADM/ MDM POLY INSERT. INTRA-OPERATIVELY, THE FOLLOWING OCCURRED: WEAR OF THE TRUNNION WAS NOTED. SURGEON ATTEMPTED TO REMOVE THE 22 +10 PROXIMAL CONE BODY, AND WHILE USING A MALLET ON THE IMPLANT EXTRACTOR, BROKE IT. NOTHING REMAINED IN THE PATIENT. THE BOLT FROM THE OLD CONE BODY WAS REMOVED, AND A BOLT FROM A NEW CONE BODY WAS IMPLANTED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24093557 ↗
• MalfunctionDec 18, 2025Fracture; Fracture

  SURGEONS WERE REMOVING A REMOVABLE HIP PROSTHESIS (RESTORATION MODULAR), WHICH WAS STUCK AND A PART OF THE BODY/STEM SEPARATOR INSTRUMENT WAS BROKEN WHEN THEY ATTEMPTED TO SEPARATE THE PROXIMAL FROM THE DISTAL PART OF THE PROSTHESIS. THE INSTRUMENT PART BROKE AT THE SAME LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23836341 ↗
• MalfunctionNov 7, 2023Fracture; Fracture

  RIGHT HIP, REVISION OF COMPETITOR IMPLANTS. IT WAS REPORTED THAT A METAL PIECE BROKE OFF OF THE DEVICES DURING SURGERY. ALL PIECES WERE RETRIEVED AND THE CASE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 1-2 MINUTES. UPDATE ON 26 OCTOBER, 2023, WG: REP REPORTED THAT THE TRIAL BODY REMOVAL DEVICE WAS DAMAGED DURING TRIALING OF THE PROXIMAL BODY. AFTER IMPLANTATION OF THE FINAL IMPLANT, SURGEON DECIDED HE WANTED A DIFFERENT VERSION ON THE PROXIMAL BODY. THE BODY/ STEM SEPARATOR WAS DAMAGED WHEN TRYING TO REMOVE THE FIRST PROXIMAL BODY.

  Patient problems: Insufficient Information

  MAUDE report 18082030 ↗
• InjuryOct 6, 2023Fracture; Fracture

  SURGEON SENT AN X-RAY, ASKED IF WE COULD PROVIDE REMOVAL EQUIPMENT FOR THE STEM. UPDATE: "DIAGNOSIS IS PERIPROSTHETIC HIP FRACTURE. PATIENT HAD GONE TO ER AFTER BEING UNABLE TO AMBULATE. THE REASON FOR REVISION WAS A FRACTURED STEM ON X-RAY. INTRA-OP FINDING WAS A BROKEN TRUNNION OF A FEMORAL STEM IMPLANT. THE IMPLANTS REVISED WERE A FEMORAL STEM, A FEMORAL HEAD, AND A SMITH AND NEPHEW POLYETHYLENE THAT WAS ARTICULATING IN THE SOCKET. THERE WERE NOT ANY ALLEGATIONS AGAINST OTHER REVISED IMPLANTS ONLY THE DICTATION FROM THE PREVIOUS SURGEON WAS AVAILABLE AS THIS WAS IMPLANTED AT A DIFFERENT INSTITUTION. THE RECORDS SHOWED THAT THE STEM WAS A RESTORATION MODULAR 23 PLUS 10 BODY AND A 16 X 155 DISTAL STEM. THE EXPLANTED HEAD WAS A 28MM PLUS 12 HEAD. AS REPORTED EVENT OCCURRING DURING REVISION PROCEDURE: LEFT HIP "THE PHYSICIAN USED [THE BODY/STEM SEPARATOR INSTRUMENT] WITH THE INTENTION OF REMOVING THE BODY, FOLLOWING THE RECOMMENDED SURGICAL TECHNIQUE. THE INSTRUMENT BROKE. THE RESULT WAS TO REMOVE THE STEM AS ONE PIECE INSTEAD OF 2, WHICH RESULTED IN DOING AN EXTENDED TROCHANTERIC OSTEOTOMY PER THE PHYSICIAN TO REMOVE THE STEM."

  Patient problems: Bone Fracture(s); Insufficient Information

  MAUDE report 17883913 ↗
• MalfunctionNov 18, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A REVISION OF THE PATIENT'S LEFT HIP, AFTER INSERTING THE BODY/ STEM SEPARATOR AND TURNING, A POP WAS HEARD BUT THE PROXIMAL CONE BODY WOULD NOT RELEASE. TURNING CONTINUED AND A SECOND POP WAS HEARD. SURGEON ELECTED TO PERFORM OSTEOTOMY AND IT WAS OBSERVED THAT THE PROXIMAL BODY WAS SEPARATED. THE SURGEON REPORTED THAT THE BONY ON-GROWTH HAD PREVENTED THE CONE BODY FROM BEING REMOVED. BODY/ STEM SEPARATOR WAS OBSERVED TO BE BROKEN. ALL PIECES WERE REMOVED FROM THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF 20-30 MINUTES. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15823517 ↗
• MalfunctionJun 7, 2022Fracture; Fracture

  REVISION OF HIP DUE TO FAILURE OF COMPETITOR SHELL AND LINER. IN PERFORMING THE REVISION, THE SURGEON WANTED TO REMOVE THE FEMORAL HEAD AND RESTORATION MODULAR CONE BODY TO ACCESS THE JOINT SPACE. AFTER THE HEAD WAS REMOVED (REPORTED BY THE REP AS NEEDING EXCESSIVE FORCE TO REMOVE IT AS IT HAD BEEN IMPACTED TOO HARD AT IMPLANTATION), THE SURGEON ATTEMPTED TO REMOVE THE CONE BODY BUT IT, TOO, WAS TOO TIGHTLY IMPACTED. THE COLLET OF THE BODY STEM SEPARATOR (6278-9-070) BROKE IN 2 PIECES. THE SURGEON USED A HEMOSTAT TO REMOVE THE BROKEN PIECES AND THE SURGEON DECIDED TO CONTINUE THE REVISION WITH THE CONE BODY LEFT IN PLACE. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14628278 ↗
• MalfunctionFeb 14, 2022Fracture; Fracture

  THREADS BROKE. UPDATE 28/JANUARY/2022: SPOKE TO REP. INSTRUMENT WAS OBSERVED WITH THREAD DAMAGE DURING A REVISION OF STRYKER HIP IMPLANTS. THERE WAS NO SURGICAL DELAY. REP CONFIRMED NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13522392 ↗
• InjuryJan 7, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A CASE THE JACK SCREW APPARATUS FROM THE RESTORATION MODULAR HIP SYSTEM BROKE. THE CUSTOMER DID NOT HAVE A BACK UP ON SITE THEREFORE THE CASE HAD TO BE POSTPONED. UPDATE PER SALES REP (B)(6) 2022: "I HAVE NO FOLLOW UP ON THIS PATIENT. I ONLY INCIDENTALLY KNOW THAT THE PATIENT WAS SENT ELSEWHERE."

  Patient problems: Unspecified Infection

  MAUDE report 13194231 ↗
• MalfunctionAug 7, 2019Break; Break

  COLLAR SNAPPED OFF OF PULLER WHILE ATTEMPTING TO DISASSOCIATE RESTORATION MODULAR PROXIMAL BODY FROM DISTAL STEM. SURGICAL DELAY OF 1 HOUR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8869209 ↗
• MalfunctionMay 21, 2019Device Damaged Prior to Use; Device Damaged Prior to Use

  DR. COULD NOT GET THE T HANDLE ON THE REST MOD CONE BODY REMOVAL TOOL. DR. DISCOVERED THAT THE TOP WHERE IT SNAPS INTO THE HANDLE WAS DAMAGED AND DID NOT ALLOW THE HANDLE TO SNAP IN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8629247 ↗
• MalfunctionFeb 21, 2019Break; Fracture; Break; Fracture

  BODY STEM SEPARATOR 6278-9-070 BROKE WHILE BEING USED IN SURGERY .THE SURGEON WAS ABLE TO REMOVE ON HIS OWN WITHOUT ANY DAMAGE TO PATIENT. NEW PROXIMAL BODY WAS USED AND CUP LINER REVISED TOO. UPDATE: THIS PI IS FOR THE INTRA-OPERATIVE INSTRUMENT BREAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 8358737 ↗
• MalfunctionOct 16, 2018Crack; Crack

  THE SURGEON WENT TO PUT IN THE CONE BODY FOR A RESTORATION MODULAR. WHEN HE IMPACTED IT THE WHITE HANDLE CRACKED ON THE CONE BODY INSERTER. THEN HE NEEDED TO CHANGE HIS VERSION SO HE USED THE BODY STEM SEPARATOR. WHILE HE USED IT HE WAS ABLE TO GET IT TO WORK, BUT THE PIECE LOOKED BENT AND HE ASKED IT BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7969690 ↗