AnatoRecalls & reported problems across all models

We found 13 models of Anato by Howmedica Osteonics Corp. in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Sep 14, 2017 and Sep 22, 2025 — classified as 22 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (14 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Anato problems

Anato models

13 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Anato 4845-7-114

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  3 reports
• Anato 4845-7-115

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
  3 reports
• Anato 4845-7-117

  Prosthesis, hip, hemi-, femoral, metal
  3 reports
• Anato 4845-7-216

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  3 reports
• Anato 4845-7-104

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  2 reports
• Anato 4845-7-116

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
  2 reports
• Anato 4845-7-107

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  1 report
• Anato 4845-7-105

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
  1 report
• Anato 4845-7-113

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  1 report
• Anato 4845-7-118

  Prosthesis, hip, hemi-, femoral, metal
  1 report
• Anato 4845-7-207

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  1 report
• Anato 4845-7-215

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  1 report
• Anato 4845-7-214

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  1 report

Recent Anato adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PERIPROSTHETIC INFECTION; ACETABULAR COMPONENTS ARE NOTED TO BE COMPETITOR DEVICES.

  Patient problems: Unspecified Infection

  MAUDE report 23107182 ↗
• InjuryAug 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "REVISION LTHA- PERIPROSTHETIC HIP FRACTURE" FEMORAL FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 15137208 ↗
• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT THE PATIENT'S RIGHT HIP WAS REVISED. PER SALES REP: "PATIENT HAD A PERIPROSTHETIC FRACTURE. STEM WAS REVISED AND REPLACED WITH A LONGER MONOLITHIC STEM. SHELL STAYED INTACT AND LINER WAS REVISED TO AN MDM." COMPARING RECORDS FROM PATIENT'S PRIOR REVISION INDICATE THAT A SIZE 7 ANATO STEM, 36 +5 BIOLOX HEAD, AND 36F 0° LINER WERE REVISED.

  Patient problems: Bone Fracture(s)

  MAUDE report 14987281 ↗
• InjuryJul 30, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AS REPORTED: "REVISION SURGERY...EXPLANTED THE ANATO STEM, 36 V40 -2.5 HEAD AND 36F 10° LINER. NO MORE INFORMATION AVAILABLE." SPOKE TO REP. SURGEON REPORTED THAT THE PATIENT'S STEM HAD SUBSIDED. THERE WERE NO ALLEGATIONS AGAINST THE REVISED HEAD OR LINER. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Failure of Implant

  MAUDE report 12252143 ↗
• InjuryMay 6, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO PAIN. A HEMI HIP CONSISTING OF AN ANATO STEM, UHR BIPOLAR COMPONENT, AND 26 -3 V40 LFIT HEAD WERE REVISED TO A TOTAL HIP. WHILE REMOVING THE ANATO STEM, AN INTRA-OPERATIVE FEMORAL FRACTURE OCCURRED AND WAS TREATED WITH 2 CABLES FROM HOSPITAL INVENTORY AND IMPLANTING A RESTORATION MODULAR STEM CONSTRUCT. WHILE IMPLANTING A 48MM SHELL, THE SHELL PASSED THROUGH THE PATIENT'S ACETABULUM (SURGEON REPORTED THIS WAS DUE TO POOR BONE QUALITY). THE SURGEON WENT TO A 50 MULTIHOLE SHELL WITH 4 SCREWS. THE SCREWS DIDN'T PROVIDE ADEQUATE FIXATION IN THE SURGEON'S OPINION (DUE TO THE PATIENT'S POOR BONE QUALITY), SO THE 50MM SHELL WAS CEMENTED IN INSTEAD. REP PROVIDED THE PRIMARY AND REVISION USAGE SHEETS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 11784571 ↗
• InjuryMay 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE INTRA-OPERATIVE EVENTS THAT OCCURRED DURING THE REVISION SURGERY: WHILE REMOVING THE ANATO STEM, AN INTRA-OPERATIVE FEMORAL FRACTURE OCCURRED AND WAS TREATED WITH 2 CABLES FROM HOSPITAL INVENTORY AND IMPLANTING A RESTORATION MODULAR STEM CONSTRUCT. WHILE IMPLANTING A 48MM SHELL, THE SHELL PASSED THROUGH THE PATIENT'S ACETABULUM (SURGEON REPORTED THIS WAS DUE TO POOR BONE QUALITY). THE SURGEON WENT TO A 50 MULTIHOLE SHELL WITH 4 SCREWS. THE SCREWS DIDN'T PROVIDE ADEQUATE FIXATION IN THE SURGEON'S OPINION (DUE TO THE PATIENT'S POOR BONE QUALITY), SO THE 50MM SHELL WAS CEMENTED IN INSTEAD. REP PROVIDED THE PRIMARY AND REVISION USAGE SHEETS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 11776021 ↗
• InjuryOct 15, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; 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) 2016 AND WAS REVISED ON (B)(6) 2017. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICES AT ISSUE AND DEVICE RECALL.

  Patient problems: Injury; Metal Related Pathology

  MAUDE report 9192771 ↗
• InjuryJul 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR THE REVISED IMPLANTS OF THE RIGHT HIP. IT WAS REPORTED THAT THE PATIENT SUFFERED BILATERAL FEMORAL FRACTURES 6 DAYS AFTER HAVING A BILATERAL HIP REPLACEMENT. THE ANATO STEMS AND BIOLOX HEADS WERE REVISED TO RESTORATION MODULAR STEM CONSTRUCTS AND BIOLOX HEADS.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 8758224 ↗
• InjuryJul 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR THE REVISED IMPLANTS OF THE LEFT HIP. IT WAS REPORTED THAT THE PATIENT SUFFERED BILATERAL FEMORAL FRACTURES 6 DAYS AFTER HAVING A BILATERAL HIP REPLACEMENT. THE ANATO STEMS AND BIOLOX HEADS WERE REVISED TO RESTORATION MODULAR STEM CONSTRUCTS AND BIOLOX HEADS.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 8758220 ↗
• InjuryMay 16, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  AS REPORTED: "[SURGEON] SAYS PATIENT COMPLAINING ABOUT PAIN AFTER PRIMARY HIP REPLACEMENT DONE...ON (B)(6) 2018...DR...BELIEVES STEM SUBSIDED. REVISION SURGERY WAS DONE AND STEM REMOVED. REPLACED WITH RESTORATION MODULAR STEM AND CONE BODY, NO OTHER INFO AVAILABLE..."

  Patient problems: Injury; Pain

  MAUDE report 8616058 ↗
• InjuryApr 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  SURGEON COMMENTED THAT THE GREATER TROCHANTER FRACTURED THROUGH THE INSERTION SITE OF THE PROXIMAL CHECKPOINT DURING THE JOINT REDUCTION WITH STEM IMPLANT AND TRIAL HEAD DURING MAKO DIRECT ANTERIOR APPROACH THA. THE SURGEON ALSO COMMENTED THAT HE DID NOT BELIEVE THAT THE CHECKPOINT CAUSED THE FRACTURE. THE FRACTURE WAS REPAIRED WITH A CERCLAGE CABLE. SURGICAL DELAY: 16-30 MINUTES.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 8503625 ↗
• InjuryMar 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  DOCTOR REPORTS PATIENT STATUS POST RIGHT TOTAL HIP DONE ON (B)(6) 2019 NOW HAS A PERIPROSTHETIC FRACTURE AROUND THE RIGHT FEMORAL COMPONENT AND HE WOULD LIKE TO REVISE TO A RESTORATION MODULAR HIP. THE SURGERY WAS PERFORMED PER RESTORATION MODULAR SURGICAL TECHNIQUE. 3 CABLES WERE APPLIED. SURGERY WAS PERFORMED WITHOUT INCIDENT. UPDATE 14/FEBRUARY/2019: AS REPORTED IN HOW WAS ISSUE NOTICED "X-RAY PATIENT COMPLAINT OF PAIN UNABLE TO AMBULATE".

  Patient problems: Hip Fracture; Injury; Pain

  MAUDE report 8403515 ↗
• InjuryJan 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT THE PATIENT'S LEFT HIP WAS REVISED. A RESTORATION MODULAR STEM CONSTRUCT, 32 +8 LFIT V40 HEAD, AND 3 DALL-MILES CABLE AND SLEEVE SETS WERE IMPLANTED. PATIENT FELL AND SUSTAINED A FEMORAL PERIPROSTHETIC FRACTURE. AN ANATO STEM AND STRYKER HEAD WERE REVISED.

  Patient problems: Fall; Injury

  MAUDE report 8272582 ↗
• MalfunctionDec 5, 2018Packaging Problem; Packaging Problem

  PRIMARY PROCEDURE, RIGHT HIP. IT WAS REPORTED THAT WHEN THE DEVICE WAS BROUGHT TO THE SURGEON AND THE OUTER BLISTER OPENED, THE INNER BLISTER WAS NOT SEALED ALL THE WAY AROUND THE LIP OF THE TRAY. THE OUTER CELLOPHANE AND OUTER BOX WERE INTACT, OUTER BLISTER INTACT WHEN BROUGHT TO THE SURGEON. SURGEON ELECTED TO USE THE IMPLANT AS ANOTHER DEVICE WAS NOT AVAILABLE. A SURGICAL DELAY OF APPROXIMATELY 2 MINUTES WAS CAUSED AS THE SURGEON TOOK TIME TO ASSESS OPTIONS. OUTER BOX AND OUTER BLISTER ONLY ARE AVAILABLE FOR RETURN (INNER BLISTER WAS BIOCONTAMINATED INTRA-OPERATIVELY AND DISPOSED).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8135800 ↗
• InjuryOct 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "PATIENT PRESENTED TO E.R. WITH PAINFUL HIP AFTER FALL. X-RAY REVEALED PERI-PROSTHETIC FRACTURE...REVISED WITH OMNIFIT EON STEM".

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 7927377 ↗

Other Howmedica Osteonics Corp. products

• Triathlon608 models · 3,524 reports · 15 recalls
• Scorpio107 models · 113 reports · 28 recalls
• Trident160 models · 1,280 reports · 2 recalls
• Accolade57 models · 1,228 reports
• Duracon58 models · 65 reports · 16 recalls
• LFIT23 models · 852 reports
• TRIDENT II42 models · 188 reports · 12 recalls
• INSTRUMENT131 models · 290 reports · 7 recalls