EXETER 0580-1-442Recalls & reported problems
Howmedica Osteonics Corp. · V40 STEM · Class 2 · Implant
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Exeter hip stem is a cemented metal-and-polymer hip replacement component. The 46 reports mostly describe the stem fracturing or breaking, sometimes requiring hip revision, along with packaging or labeling mix-ups; they include 27 injuries and no deaths. There is 1 open recall, begun in August 2025, because packages may contain the wrong stem and patient labels may be affected. Reports fell from 14 to 5 over the latest 12-month periods.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 46
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 04546540153319), received between Jan 11, 2018 and Apr 28, 2026 — classified as 27 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Fracture” (15 reports).
1 FDA recall record name this device's identifier, 1 still open.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Aug 28, 2025Open, Classified
a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.
Z-2640-2025 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Fracture15
- Product Quality Problem14
- Break7
- Adverse Event Without Identified Device or Use Problem6
- Material Deformation4
- Crack2
- Degraded2
- Fitting Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- Injury11
- Ambulation or Postural Difficulties8
- Bone Fracture(s)4
- Insufficient Information4
- No Consequences Or Impact To Patient4
- Pain4
- Fall3
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO FEMORAL FRACTURE. A PLATE, SCREWS, AND CABLES WERE IMPLANTED (NO OTHER HIP IMPLANTS WERE IMPLANTED).
Patient problems: Periprosthetic fracture
MAUDE report 25018849 ↗MalfunctionMar 23, 2026Product Quality Problem
THIS MDR IS FOR THE STEM IMPLANTED ON (B)(6) 2025. WHEN I WAS FOLLOWING UP ON PRODUCT FIELD ACTION RESPONSES, A CUSTOMER NOTED THAT THEIR TWO STEMS WERE ALREADY IMPLANTED INTO PATIENTS. BOTH SURGEONS WERE SATISFIED WITH THE OUTCOMES OF THE PROCEDURES AND HAVE NOT REPORTED ANY ISSUES RELATED TO THE SIZE OF THE IMPLANTS; NO NEGATIVE IMPACTS NOTED BY THE PATIENTS. DATE OF IMPLANTS WERE (B)(6) 2025 & (B)(6) 2025 - THE PFA AND COMMUNICATIONS TO CUSTOMERS WERE SENT ON (B)(6) 2025. FROM THE CUSTOMER (LEAD THEATRE PRACTITIONER): "THE EXETER V40 STEM WAS IMPLANTED ON (B)(6) 2025 AND AGAIN ON (B)(6) 2025. I HAVE CONFIRMED WITH BOTH SURGEONS THAT THEY ARE SATISFIED WITH THE OUTCOMES OF THE PROCEDURES. FURTHERMORE, THEY HAVE NOT REPORTED ANY ISSUES RELATED TO THE SIZE OF THE IMPLANTS, NOR HAVE THERE BEEN ANY NEGATIVE IMPACTS NOTED BY THE PATIENTS AT THIS TIME."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24663114 ↗MalfunctionMar 4, 2026Product Quality Problem
THIS REPORT IS FOR THE STEM IMPLANTED ON (B)(6) 2025. WHEN I WAS FOLLOWING UP ON PRODUCT FIELD ACTION RESPONSES, A CUSTOMER COPIED ME INTO AN EMAIL CHAIN AND NOTED THAT A STEM WAS ALREADY IMPLANTED INTO PATIENT. SURGEON WAS SATISFIED WITH THE OUTCOMES OF THE PROCEDURE AND HAS NOT REPORTED ANY ISSUES RELATED TO THE SIZE OF THE IMPLANT. NO NEGATIVE IMPACTS NOTED BY THE PATIENT. DATE OF IMPLANT WAS (B)(6) 2025: THE PFA AND COMMUNICATIONS TO CUSTOMERS WERE SENT ON (B)(6) 2025. FROM THE CUSTOMER (LEAD THEATRE PRACTITIONER): "THE EXETER V40 STEM WAS IMPLANTED ON (B)(6) 2025. I HAVE CONFIRMED WITH SURGEON THAT THEY ARE SATISFIED WITH THE OUTCOMES OF THE PROCEDURE. FURTHERMORE, THEY HAVE NOT REPORTED ANY ISSUES RELATED TO THE SIZE OF THE IMPLANT, NOR HAVE THERE BEEN ANY NEGATIVE IMPACTS NOTED BY THE PATIENT AT THIS TIME."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24508528 ↗MalfunctionJan 29, 2026Product Quality Problem
THE FOLLOWING INFORMATION WAS PROVIDED: I HAVE JUST RECEIVED A CALL FROM THE HEAD OF MEDICAL PHYSICS WHO HAS JUST BEEN ALERTED TO A POTENTIAL IMPLANTATION OF ONE OF THE EXETER STEMS THAT WERE PART OF FIELD SAFETY NOTICE LAST YEAR. THIS WAS AN ISSUE WHERE THERE WAS A POTENTIAL MISLABELING WITH THE WRONG OFFSET. THE PATIENT WAS OPERATED ON MONDAY THIS WEEK AND THIS HAS ONLY JUST COME TO LIGHT; HE WAS THEN GOING TO SPEAK WITH THE SURGEON TO DISCUSS THIS. AS PER THE SURGEON: "AS OF YESTERDAY, THE PATIENT IS STABLE AND THE SURGEON WAS HAPPY THAT THE HIP WAS STABLE ON THE TABLE ONCE THE HIP HAD BEEN REDUCED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24208860 ↗InjuryNov 3, 2025Fracture; Fracture
THE FOLLOWING INFORMATION WAS PROVIDED: THE CUSTOMER REPORTED THAT THE PATIENT HAD A PRIMARY TOTAL HIP REPLACEMENT IN 2017. THE EXETER STEM BROKE AT THE NECK WHILE THE PATIENT WAS RUNNING.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 23457967 ↗MalfunctionOct 17, 2025Product Quality Problem; Product Quality Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23321676 ↗MalfunctionOct 17, 2025Product Quality Problem; Product Quality Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23321675 ↗MalfunctionOct 17, 2025Product Quality Problem; Product Quality Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23321672 ↗MalfunctionOct 17, 2025Product Quality Problem; Product Quality Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23321665 ↗MalfunctionOct 17, 2025Product Quality Problem; Product Quality Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23321664 ↗MalfunctionOct 17, 2025Product Quality Problem; Product Quality Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23321158 ↗MalfunctionOct 17, 2025Product Quality Problem; Product Quality Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23321156 ↗MalfunctionOct 17, 2025Product Quality Problem; Product Quality Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23321155 ↗MalfunctionOct 17, 2025Product Quality Problem; Product Quality Problem
AS REPORTED BY THE REP: "SURGEON REQUESTED FOR A 44/2 EXETER STEM TO BE OPENED, THE OUTSIDE BOX AND INSIDE STICKERS WERE CHECKED BY SURGEON AND SCRUB STAFF, BOTH WERE CORRECT. HOWEVER, AFTER CEMENTING THE SURGEON DECIDED TO CHECK THE LASER MARKING ON THE STEM AS SOMETHING SEEMED AMISS, THE CODE ON THE STEM WAS ACTUALLY: 0580-1-352 WHICH CORRESPONDS TO A 37.5/0 EXETER STEM. NO OTHER STEMS WERE OPENED DURING THAT CASE AND STICKERS AND BOX WERE CHECKED AGAIN SHOWING: 0580-1-442, A 44/2 150MM EXETER STEM. SURGEON USED A PLUS HEAD INSTEAD OF A MINUS HEAD, WITH THE SMALLER STEM TO ACCOUNT FOR THE DIFFERENCE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23321154 ↗MalfunctionOct 17, 2025Product Quality Problem; Product Quality Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23321153 ↗MalfunctionOct 17, 2025Product Quality Problem; Product Quality Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23321149 ↗InjuryAug 29, 2025Fracture; Fracture
InjuryAug 28, 2025Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem
InjuryJan 28, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
DISLOCATION OF HIP, SURGEON HAS REQUESTED THE FEMORAL HEAD BE CHECKED IF IT IS INDEED A +4 HEAD OFFSET. MDM IMPLANTS USED WITH EXETER TRIDENT. THE HEAD DISLOCATED (DISASSOCIATED) FROM THE STEM, BUT ALSO THE INNER HEAD DISENGAGED FROM THE OUTER MDM HEAD.
Patient problems: Joint Dislocation
MAUDE report 21252078 ↗InjuryMar 4, 2024Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
AS REPORTED BY THE CUSTOMER: "(B)(6) DID A REVISION TOTAL HIP REPLACEMENT THIS MORNING AND HE TOOK OUT AN EXETER STEM WHICH, ACCORDING TO HIM, HAS FAILED. HE WANTS THIS STEM/ IMPLANT TO BE SENT FOR ANALYSIS." ADDITIONAL INFORMATION: SLIPPED ON A WET FLOOR (AWKWARD TWIST NOT DIRECT FALL ON TO THE HIP). REVISION OPERATIVE REPORT NOTES THE PRE-OP DIAGNOSIS AS PERIPROSTHETIC FRACTURE OF RIGHT HIP.
Patient problems: Fall; Insufficient Information
MAUDE report 18833889 ↗InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS PI WAS OPENED TO CAPTURE THE FIRST REVISION SURGERY FOR THIS PATIENT'S PERIPROSTHETIC FEMUR FRACTURE. STEM & HEAD WAS REMOVED AND FRACTURE STABILISED WITH PLATES, SCREWS & WIRES OF COMPETITOR, IMPLANTED A CEMENT-IN-CEMENT EXETER STEM & DELTA HEAD.
Patient problems: Bone Fracture(s)
MAUDE report 17972599 ↗InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT ADMITTED FOR SURGERY FOLLOWING PERIPROSTHETIC FRACTURE. IMPLANTS REMOVED. REPLACEMENT DEVICE IMPLANTED.
Patient problems: Bone Fracture(s)
MAUDE report 17740975 ↗InjuryJan 4, 2023Break; Fracture; Break; Fracture
PEROPROSTHETIC BREAK OF EXETER IMPLANT, EXTREMELY PROXIMAL ON TRUNNION.
Patient problems: Bone Fracture(s); Insufficient Information
MAUDE report 16092711 ↗InjurySep 8, 2022Corroded; Material Erosion; Corroded; Material Erosion
PATIENT WAS REVISED DUE TO HIGH METAL ION LEVELS. EXETER/MITCH COMBINATION REVISED.
Patient problems: Foreign Body Reaction; Metal Related Pathology
MAUDE report 15377935 ↗InjuryFeb 25, 2022Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem
THE FOLLOWING WAS REPORTED: THE PATIENT HAD AN EXETER/MITCH THR REVISION.
Patient problems: Insufficient Information; Metal Related Pathology
MAUDE report 13602776 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.