ABG 4845-0106Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327051018), received between Apr 18, 2018 and Apr 14, 2023 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  PROSTHETIC STEM COLLAR BREAKING. PATIENT WITH CLEAR SURGICAL WOUND AFTER REVIEW OF RIGHT HIP PROSTHESIS FOR COLLAR BREAK. SURGICAL WOUND DEHISCENCE AFTER RIGHT HIP PROSTHESIS REVISION. UPDATE : THE SURGICAL WOUND DEHISCENCE MENTIONED IN THE REPORTED DETAILS REFERS TO AN ADVERSE EVENT THAT OCCURRED POST-REVISION OF STRYKER DEVICES. THE PATIENT WAS LATER REVISED ON (B)(6) 2023 (COMPETITOR DEVICES) DUE TO INFECTION/WOUND DEHISCENCE. THIS PI IS FOR THE REVISION OF STRYKER PRODUCTS WHICH OCCURRED ON (B)(6) 2023 DUE TO STEM FRACTURE DURING WHICH COMPETITOR DEVICES WERE IMPLANTED.

  Patient problems: Insufficient Information; Wound Dehiscence

  MAUDE report 16741074 ↗
• InjuryNov 25, 2020Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  PATIENT GOT A RIGHT HIP REVISION DUE TO ¿SQUEAKING¿ COMPLAINTS. PATIENT COMPLAINT OF GRINDING, POPPING FEELING AND AUDIBLE SQUEAK AND GRINDING. PATIENT ALSO EXPERIENCING PAIN. CUP AND LINER WERE WELL FIXATED. HEAD EASILY REMOVED FROM TRUNNION. NO MARKED STRIPING ON CERAMIC LINER OR OUTER HEAD - BUT BROWN DISCOLOURATION INSIDE HEAD. HEAD LOOSE ON TRUNNION. RUST MARKS ON CUP RIM. FEMORAL STEM UNREMARKABLE, FIXATED AND RETAINED.

  Patient problems: Pain

  MAUDE report 10903549 ↗
• InjuryJul 1, 2020Fracture; Loss of Osseointegration; Migration; Fracture; Loss of Osseointegration; Migration

  A R ABG STEM AND HEAD WAS REVISED TO A RESTORATION MODULAR STEM. THE REASON GIVEN FOR THE REVISION BY THE SURGEON WAS PERIPROSTHETIC FRACTURE WHICH LED TO LOOSENING AND SUBSIDENCE OF THE STEM.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; Injury; Pain

  MAUDE report 10217266 ↗
• InjuryAug 30, 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 HIS RIGHT HIP ON OR ABOUT (B)(6) 2011. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. THE PATIENT WILL HAVE THE FEMORAL HEAD AT ISSUE EXPLANTED ON OR ABOUT (B)(6) 2018.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 7835187 ↗
• MalfunctionApr 18, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE HYDROXYAPATITE COATING OVERLAID THE ROUGHENED AREA SUPERIOR ABOUT 1MM ON THE POLISHED SURFACE. THE COATING COULD BE REMOVED FROM THE POLISHED AREA DURING IMPLANTATION AND WITH TWEEZERS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7440322 ↗