Restoration 6276-1-019Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04546540641069), received between Jun 20, 2017 and Jun 12, 2023 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT OCCURRED DURING CONVERSION OF A FEMORAL NAIL TO A LEFT HEMI HIP. WHEN IMPACTING THE CONE BODY ON TO THE DISTAL STEM, THE PATIENT'S FEMUR FRACTURED. THE STEM CONSTRUCT WAS IMPLANTED AND TWO CABLE AND SLEEVE SETS WERE ADDED. PROCEDURE COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 10 MINUTES.

  Patient problems: Bone Fracture(s)

  MAUDE report 17114799 ↗
• MalfunctionApr 26, 2023Fracture; Fracture

  REVISION OF COMPETITOR NAIL, LEFT HIP. IT WAS REPORTED THAT THE SCREW THAT COMES WITH THE PROXIMAL BODY BROKE OFF IN THE DISTAL STEM. SURGEON WAS NOT COMFORTABLE WITH THE STEM CONSTRUCT LACKING FULL LOCKING STRENGTH. ALL PIECES WERE REMOVED AND A NEW STEM CONSTRUCT WAS IMPLANTED. SURGERY COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 10 MINUTES. SURGEON IS VERY EXPERIENCED WITH THE RESTORATION MODULAR SYSTEM, AND WAS USING THE FINAL TORQUE TIGHTENER WHEN THE SCREW BROKE. REP ASKED SPD TO RETAIN ALL PARTS FOR RETURN. OTHERWISE, REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16814554 ↗
• InjurySep 18, 2022Degraded; Material Erosion; Degraded; Material Erosion

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS RIGHT HIP ON OR ABOUT (B)(6), 2013 AND WAS REVISED ON (B)(6), 2022. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE(S) AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 15443350 ↗
• InjuryDec 30, 2019Fracture; Fracture

  AS REPORTED: "PATIENT PRESENTED WITH PAIN OF THE LEFT HIP. X-RAYS DEMONSTRATED A FRACTURED FEMORAL COMPONENT (PERIOPERATIVE MANAGEMENT REPORT STATES "FRACTURE OF THE FEMORAL STEM AT THE MODULAR JUNCTION"). PATIENT WAS REVISED TO ANOTHER FEMORAL COMPONENT FROM A DIFFERENT MANUFACTURER. THE ACETABULAR COMPONENT WAS RETAINED." A RESTORATION MODULAR STEM CONSTRUCT AND 40 +0 V40 HEAD WERE REVISED.

  Patient problems: Ambulation or Postural Difficulties; Injury; Pain

  MAUDE report 9530706 ↗
• InjuryNov 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR THE REPORTED REVISION OF THE PATIENT'S HIP. AS REPORTED: "DR. WANTED TO REPLACE THE CONE BODY AND HEAD THE PATIENT HAD PREVIOUSLY HAD IMPLANTED ON (B)(6) 2014, AND CONVERT LINER TO MDM. WHEN TRYING TO SEPARATE THE CONE BODY FROM THE STEM, THE EXTRACTOR PIECE BROKE. WE HAD A BACKUP SET AT THE HOSPITAL, BUT THE SAME PIECE BROKE AGAIN, BUT HE WAS ABLE TO REMOVE THE CONE BODY FROM THE STEM." UPDATE: REASON FOR REVISION- LINER EXCHANGE, WITH HEAD, MDM, AND COME BODY EXCHANGE AS WELL DUE TO SUSPICION OF INFECTION THIS SURGERY WAS A REVISION OF A REVISION. BODY SIDE: LEFT.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9336374 ↗
• InjuryDec 10, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED DUE TO DISLOCATION. THE HEAD DISLOCATED FROM THE LINER AS A RESULT OF THE PROXIMAL BODY DISASSOCIATING FROM THE PLASMA STEM AND PULLING THE HEAD OUT OF THE LINER. PATIENT HAD BEEN PERFORMING A NON-COMPLIANT ACTIVITY (BENDING OVER) WHEN DISLOCATION/ DISASSOCIATION OCCURRED. SURGEON REPORTED HE WAS UNSURE IF THE DISASSOCIATION OCCURRED BECAUSE OF SURGEON ERROR OR DEVICE FAILURE OF THE LOCKING MECHANISM. REP NOTED THAT DURING IMPLANTATION, SURGEON DID NOT USE TORQUE WRENCH, BUT APPLIED FORCE BY FREE-HAND TIGHTENING THE LOCKING MECHANISM. A BIOLOX CERAMIC HEAD AND RESTORATION PROXIMAL BODY WERE REVISED TO THE SAME CATALOG NUMBERS OF DIFFERENT LOT CODES AS THE SURGEON DECIDED NOT TO RE-IMPLANT THE REVISED DEVICES.

  Patient problems: Injury

  MAUDE report 8146438 ↗
• InjuryOct 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HER RIGHT HIP ON OR ABOUT (B)(6) 2014. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL, AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD. THE PATIENT HAS NOT YET SCHEDULED A SURGERY FOR EXPLANTATION OF THE FEMORAL HEAD.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 8010724 ↗
• InjuryApr 9, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REP REPORTED "PATIENT'S PELVIS FRACTURED ABOVE THE SADDLE DURING PHYSICAL THERAPY AND WILL HAVE TO BE REVISED. BEYOND THE REPORTED ILIAC WING FRACTURE, THERE IS THE PROBLEM OF DISLOCATION BETWEEN FEMORAL COMPONENT AND PELVIC PROSTHESIS WITH APPARENT DISASSOCIATION BETWEEN FEMORAL HEAD AND ANGLE ADAPTER TO THE FEMORAL STEM."

  Patient problems: Bone Fracture(s); Injury; Joint Dislocation

  MAUDE report 7409668 ↗
• InjuryAug 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT PRESENTED WITH AN INFECTION OF THE RIGHT HIP BACK ON (B)(6) 2017. IMPLANTS WERE REMOVED BUT DISTAL STEM WAS WELL FIXED AND WAS LEFT BEHIND. OSTEOTOMY WAS PERFORMED AND STEM WAS REMOVED. NEW RESTORATION MODULAR STEM AND BODY WERE ADDED AND TRITANIUM REVISION CUP AND MDM LINERS WERE IMPLANTED.

  Patient problems: Injury

  MAUDE report 6807092 ↗
• InjuryJun 20, 2017Malposition of Device; Positioning Problem; Insufficient Device Problem Information; Malposition of Device; Positioning Problem; Insufficient Device Problem Information

  COMPANY REPRESENTATIVE REPORTED THAT THE PATIENT'S ORIGINAL SURGERY WAS PERFORMED IN (B)(6) AND REVISED IN (B)(6) 2017. THEN AGAIN TODAY BECAUSE OF IMPINGEMENT. PROXIMAL BODY WAS REMOVED, CUP WAS REMOVED AND NEW CUP & PROXIMAL BODY HEAD WERE REPOSITIONED.

  Patient problems: Injury

  MAUDE report 6654175 ↗