Restoration 6276-1-321Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613154057917), received between Jul 6, 2020 and Apr 28, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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.

• InjuryApr 28, 2026Device Dislodged or Dislocated

  THE FOLLOWING INFORMATION WAS PROVIDED: AS REPORTED BY HCP: I JUST RECEIVED WORD THAT OUR COMPASSIONATE USE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT FROM THE ORTHO CLINIC. PATIENT HAD HER 8 WEEK FOLLOW UP IN CLINIC TODAY WITH COMPLAINTS OF NEW ONSET RIGHT HIP PAIN AND CLICKING FOR THE LAST 2 WEEKS. ON X-RAY, THE HIP WAS FOUND TO BE DISLOCATED. SHE HAS BEEN ADMITTED TO THE HOSPITAL AND WILL HAVE A REVISION TOMORROW. WE'LL KNOW MORE TOMORROW. PER PSS TEAM: A PATIENT SPECIFIC FLANGED ACETABULAR CUP (P/N: C-MM100731-00) WAS IMPLANTED. ADDITIONAL INFORMATION FROM SALES REP: THE ENTIRE ((B)(6) 2026) REVISION WAS STRYKER PROJECTS WITH REST MOD IN THE FEMUR AND MDM CONSTRUCT IN THE CUP (NOTE: THE (B)(6) 2026 SURGERY TO IMPLANT STRYKER IMPLANTS WAS A REVISION OF NON-STRYKER IMPLANTS). THE REASON FOR THE DISLOCATION WAS A BRACE WAS REMOVED FROM THE PATIENT DURING PT (BRACE WAS REMOVED BY PHYSICAL THERAPIST AGAINST SURGEON ADVICE AFTER HAVING BEEN ASKED 3 TIMES TO REMOVE THE BRACE) AND HER ENTIRE GREATER TROCHANTER BROKE OFF DUE OVER MOVEMENT OF THE OPERATIVE LEG. IT WAS DISCOVERED YESTERDAY, IN SURGERY, THAT HER ABDUCTORS WERE NO LONGER ATTACHED TO KEEP THE HIP IN PLACE. THE MDM CONSTRUC

  Patient problems: Joint Dislocation

  MAUDE report 25017086 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ITS REPORTED BY THE ATTORNEY, THROUGH THE FILING OF A LAWSUIT, THAT THE PLAINTIFF UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2017. ITS FURTHER ALLEGED THAT ELEVATED LEVELS OF CHROMIUM AND COBALT WERE REVEALED IN BLOOD WORK. PLAINTIFF HAS NOT YET BEEN REVISED.

  Patient problems: Metal Related Pathology

  MAUDE report 19389026 ↗
• InjuryMar 25, 2021Fracture; Patient Device Interaction Problem; Fracture; Patient Device Interaction Problem

  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) 2009 AND WAS REVISED ON (B)(6) 2016. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. UPDATE: THE REVISION OPERATIVE REPORT STATES ¿HE REPORTS THAT ABOUT 2 MONTHS AGO HE HAD SEVERE ONSET OF SEVERE PAIN IN THE RIGHT THIGH AREA. HE CAME TO MY OFFICE FOR EVALUATION. X-RAYS WERE OBTAINED OF THE RIGHT HIP AND THESE DEMONSTRATED WHAT APPEARED TO BE MALALIGNMENT OF THE MODULAR FEMORAL COMPONENT IN THE FEMUR. THE ANGLE APPEARED DIFFERENT FROM PREVIOUS X-RAYS SUGGESTING FRACTURE OF THE DISTAL SEGMENT OF THE MODULAR STEM.¿ THE FEMORAL STEM WAS BROKEN AT THE TRUNNION OF THE DISTAL SEGMENT.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 11569293 ↗
• InjuryJul 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PLAINTIFF WAS IMPLANTED WITH A HOWMEDICA RESTORATION MODULAR HIP SYSTEM, REFERENCE NO. 6276-1-321 UPON INFORMATION AND BELIEF CONTAINING A REJUVENATE OR ABG II MODULAR HIP STEM ON HIS RIGHT HIP ON OR ABOUT (B)(6) 2010. PLAINTIFF HAS NOT HAD THE RIGHT HIP STEM EXPLANTED AT THE PRESENT TIME; HOWEVER, HE HAS EXPERIENCE SEVERE PAIN AND COMPLICATIONS RELATED TO THE RIGHT HIP STEM AND WAS SEEN FOR SAID PAIN ON (B)(6) 2014 AT (B)(6) MEDICAL CENTER EMERGENCY ROOM. PLAINTIFF HASN'T BEEN REVISED. THIS PI IS FOR THE SEVERE PAIN AND COMPLICATIONS RELATED TO THE RESTORATION MODULAR HIP SYSTEM.

  Patient problems: Pain

  MAUDE report 10233111 ↗