Restoration 6276-7-122Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613154058686), received between Apr 25, 2022 and Apr 25, 2022 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING CUP IMPACTION OF A RECENT THA CASE, WE RESULTED IN HAVING ACETABULAR FRACTURES. SURGICAL DELAY > 30 MINUTES. CASE TYPE / APPLICATION: THA. UPDATE 01/APRIL/2022: PER MPS: PLEASE PROVIDE DETAILS AS TO ALL MEASURES TAKEN TO ADDRESS THE ACETABULAR FRACTURES: PLATING THE POSTERIOR ACETABULUM WALL. FURTHER FRACTURES WERE NOT DISCOVERED UNTIL LATER ON. IT WAS REPORTED THE SHELL WAS PART OF THE FRACTURE EVENT IMPLANTED BUT REMOVED THE FOLLOWING DAY FOR A REVISION CUP. UPDATE: IT HAS BEEN REPORTED THAT IMPLANT MALPOSITION DID NOT CAUSE OR CONTRIBUTE TO THIS EVENT. IT HAS BEEN REPORTED TOO MUCH FORCE OR OVERSIZED CUP LEAD TO THIS. (PERIPROSTHETIC FRACTURE ONLY) IT HAS BEEN REPORTED THAT NO BONE PIN HOLES HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. UPDATE 14/APRIL/2022: PER MPS: INTRA-OPERATIVELY ON (B)(6) 2022, A DISTAL FEMORAL FRACTURE HAD ALSO BEEN NOTICED VIA C-ARM. ON (B)(6) 2022, THE PATIENT WAS REVISED TO COMPETITOR ACETABULAR COMPONENTS, RESTORATION MODULAR PROXIMAL BODY, FEMORAL HEAD, AND THREE CABLE AND SLEEVE SETS.

  Patient problems: Bone Fracture(s)

  MAUDE report 14192094 ↗