CORAIL L971110Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295455295), received between Sep 6, 2018 and Sep 8, 2025 — classified as 9 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN INITIAL SURGERY VIA THA FOR OA ON HIP JOINT WITH THE PRODUCTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, THE SALES REP WAS INFORMED THAT THE PATIENT IS SUSPECTED OF HAVING A DISLOCATION AND INFECTION, THEREFOR REVISION SURGERY IS SCHEDULED FOR (B)(6) 2025. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 22998411 ↗
• InjurySep 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME. DOI- UNKNOWN. DOR- (B)(6) 2023. AFFECTED SIDE- LEFT HIP.

  Patient problems: Pain

  MAUDE report 17710957 ↗
• InjuryMar 22, 2023Use of Device Problem; Osseointegration Problem; Use of Device Problem; Osseointegration Problem

  PATIENT'S PAINFUL HIP WAS REVISED DUE TO LOOSE STEM. NO SIGN OF INFECTION. SURGEON BELIEVED STEM WAS POTTED DISTALLY AND THAT LED TO LOOSENING. IMPLANTS ARE UNAVAILABLE FOR RETURN. NO SURGICAL DELAY WAS REPORTED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 16592057 ↗
• MalfunctionNov 10, 2022Inaccurate Information; Wrong Label; Inaccurate Information; Wrong Label

  IT WAS REPORTED THE LITTLE SQUARE ON THE PRODUCT IS SUPPOSED TO BE YELLOW, BUT ITS BRIGHT PINK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15777382 ↗
• InjuryFeb 23, 2022Osseointegration Problem; Osseointegration Problem

  REVISION OF A CORAIL PINNALE THR. THE STEM HAD BECOME LOOSE. SPEAKING TO THE REGISTRAR PRIOR TO THE CASE, HE SAID IT LOOKED LIKE THE STEM HAD BEEN UNDERSIZED AS IT WAS PUT IN VARUS. PATIENT DID NOT HAVE AN INFECTION. THE 56 PINNACLE CUP WAS WELL FIXED. THE STEM, HEAD, AND LINER WERE EXPLANTED. I WASN'T AT THE CASE, I JUST GOT THIS INFORMATION AFTER. I WAS UNABLE TO GET THE LOT NUMBERS OF THE HEAD AND LINER, BUT THE TEAM SENT ME A PHOTO SHOWING THE LOT NUMBER ON THE STEM, HOPEFULLY YOU CAN MATCH THESE UP WITH THE PATIENT. NHI IS NYC3202. THE CODES WERE 136532320 FOR THE HEAD AND 121932056 FOR THE LINER. THEY IMPLANTED A ZIMMER MS30 STEM AND A DEPUY LINER 1219-36-156 LOT JF7383 AND HEAD 1365-36-720 LOT 9285560. DOI: UNK. DOR: (B)(6) 2022. UNKNOWN HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13585799 ↗
• InjuryJan 14, 2022Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE FEMORAL STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2020; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 13257547 ↗
• InjuryNov 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANTS REMOVED DURING REVISION DUE TO INFECTION. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 12882075 ↗
• InjurySep 16, 2021Osseointegration Problem; Osseointegration Problem

  1. CAN YOU CONFIRM THE PRIMARY SURGERY DATE OR THE ORIGINAL IMPLANTATION DATE? (B)(6) 2010. 2. CAN YOU PLEASE PROVIDE THE DATE THE PATIENT WAS REVISED? (B)(6) 2021. 3. WHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT? RIGHT. 4. PLEASE PROVIDE THE LOOSENING INTERFACE OF THE LOOSE STEM. BONE / IMPLANT. 5. PLEASE PROVIDE THE PRODUCT AND LOT NUMBER OF ALL EXPLANTED PRODUCTS. NA. 6. WAS THERE ANY SUGGESTION BY ANYONE INDICATING THAT THERE WAS OR MAY BE DEFICIENCY WITH THE OTHER PRODUCT(S)? IF YES PLEASE ENSURE DETAILS. NO.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 12485941 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED TO TREAT INFECTION. DOI: (B)(6) 2021, DOR: (B)(6) 2021, UNKNOWN HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12211971 ↗
• MalfunctionOct 22, 2020Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  FORTH VALLEY HOSPITAL HAD AN ISSUE WITH A PACKAGING ON A CORAIL STEM. WHEN THEY OPENED THE OUTER PACKAGING, THE CELLOPHANE, AND THE BOX WERE INTACT. BUT THE PACKAGING FOR THE BIT THE FLOOR NURSE OPENS FOR THE SCRUB NURSE TO STERILE HAD A SMALL PUNCHER HOLE.

  Patient problems: No Code Available

  MAUDE report 10717680 ↗
• MalfunctionNov 13, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE SURGEON ASKED FOR KHO COLLARED SIZE 10 STEM. UPON BOX BEING OPENED, A HOLE WAS NOTICED IN THE STERILE PACKAGING WHICH COMPROMISED THE STERILITY OF THE STEM. THEY GOT THE OTHER SIZE 10 KHO COLLARED IMPLANT AT THE FACILITY AND THAT WAS USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9314840 ↗
• InjurySep 6, 2018Fracture; Failure to Osseointegrate; Fracture; Failure to Osseointegrate

  X-RAY IS ATTACHED. PATIENT ORIGINALLY HAD A TOTAL HIP REPLACEMENT ON (B)(6) 2017 AND THE ORIGINAL IMPLANTS ARE AS FOLLOWS: REF: L971110 (TO BE RETURNED), LOT: 8328858, DESCRIPTION: SZ10 HO COLLARED CORAIL STEM; REF: 121731052 (IMPLANTED), LOT: C28818, DESCRIPTION: 52MM GRIPTION 100; REF: 121932052 (IMPLANTED), LOT: 728810, DESCRIPTION: 32MM X 52MM NEUTRAL LINER; REF: 136532320 (TO BE RETURNED), LOT: 8417808, DESCRIPTION: +5 32MM DELTA CERAMIC HEAD; REF: 124603000 (IMPLANTED), LOT: D16102057, DESCRIPTION: HOLE ELIMINATOR. PATIENT PRESENTED TO A&E WITH PAIN - NO TRAUMA - JUST BEEN WALKING. FRACTURED FEMORAL STEM IMPLANT. DISTAL FRAGMENT WAS VERY WELL FIXED/BONDED - HAD TO BE REMOVED WITH TREPHINES. PROXIMAL FRAGMENT CAME OUT EASILY AND STILL HAS HA COATING ON. WE HAVE REMOVED THE FEMORAL STEM BUT LEFT THE ACETABULAR IMPLANTS IN SITU.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 7850196 ↗