V40 HeadRecalls & reported problems across all models

We found 30 models of V40 Head by Howmedica Osteonics Corp. in the FDA's device registry (GUDID). Together they are named in 229 adverse event reports in the FDA's MAUDE database, received between Nov 17, 2015 and Feb 2, 2026 — classified as 208 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (71 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 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. 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

V40 Head recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Dec 21, 2021Open, Classified

   There is a potential for the outer Tyvek lid to de-bond from the sealed package.

   Z-0644-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Oct 15, 2021Open, Classified

   There is a potential for the outer white Tyvek lid to debond from the sealed package.

   Z-0314-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Oct 15, 2021Open, Classified

   XXX

   Z-0313-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported V40 Head problems

V40 Head models

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

• V40 Head 6260-9-122

  Prosthesis, hip, hemi-, femoral, metal
  1 recall10 reports
• V40 Head 6260-5-032

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
  1 recall8 reports
• V40 Head 6260-9-028

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  1 recall5 reports
• V40 Head 6260-9-132

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  26 reports
• V40 Head 6260-9-232

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  23 reports
• V40 Head 6260-9-332

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  22 reports
• V40 Head 6260-5-332

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
  12 reports
• V40 Head 6260-5-232

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  11 reports
• V40 Head 6260-9-032

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
  11 reports
• V40 Head 6260-9-228

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
  11 reports
• V40 Head 6260-9-328

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
  10 reports
• V40 Head 6260-9-128

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
  9 reports
• V40 Head 6260-5-128

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  6 reports
• V40 Head 6260-5-132

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
  6 reports
• V40 Head 6260-5-228

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  6 reports
• V40 Head 6260-9-222

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  6 reports
• V40 Head 6260-4-122

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  5 reports
• V40 Head 6260-5-226

  Prosthesis, hip, hemi-, femoral, metal
  5 reports
• V40 Head 6260-9-432

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  5 reports
• V40 Head 6260-5-026

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
  4 reports
• V40 Head 6260-5-028

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
  4 reports
• V40 Head 6260-5-126

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
  4 reports
• V40 Head 6260-9-126

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  4 reports
• V40 Head 6260-9-322

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  4 reports
• V40 Head 6260-5-328

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
  3 reports
• V40 Head 6260-9-026

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  3 reports
• V40 Head 6260-9-428

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  3 reports
• V40 Head 6260-5-428

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
  1 report
• V40 Head 6260-5-628

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  1 report
• V40 Head 6260-9-226

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
  1 report

Recent V40 Head adverse event reports

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

• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: EXPLANTED ALL LEFT HIP IMPLANTS DUE TO CHRONIC INFECTION AND PLACED A TEMPORARY CEMENT SPACER. ORIGINAL PRIMARY WAS A COMPETITOR HIP IN 2014. THE STEM WAS REVISED TO A REST MOD ON (B)(6) 2025 AND THEN ON (B)(6) 2025 IT WAS CONVERTED TO A CONSTRAINED LINER.

  Patient problems: Unspecified Infection

  MAUDE report 24240513 ↗
• InjuryDec 22, 2025Material Erosion; Material Erosion

  AS REPORTED VIA MW5178956: DIAGNOSED WITH TOXIC COBALT METALLOSIS MOSTLY LIKELY RESULTING FROM A STRYKER LFIT V40 FEMORAL HIP REPLACEMENT IN 2015. COBALT LEVEL WAS 7.4UG/L VS A .1 TO .8 SUGGESTED SAFE RANGE. MANY SIDE EFFECTS WHICH COULD ALSO INCLUDE THE REASON FOR MY CHRONIC KIDNEY DISEASE. ALSO HAD X-RAY, MRI, AND CT SCANS. PREVIOUS COBALT PLASMA TEST WAS 638UG/L 2 WEEKS PRIOR.

  Patient problems: Metal Related Pathology

  MAUDE report 23863638 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: Unspecified Infection

  MAUDE report 23594787 ↗
• InjuryJun 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  CLAIMANT, THROUGH COUNSEL, ALLEGES THAT HE UNDERWENT A RIGHT THA ON (B)(6) 2010, AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND AN ACCOLADE TMZF STEM. HE SUBSEQUENTLY WAS REVISED ON (B)(6) 2024, DUE TO ALLEGED HEAD DISASSOCIATION.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 22311014 ↗
• InjuryMay 20, 2025Degraded; Patient-Device Incompatibility; Degraded; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED:" AROUND AUTUMN 2024, THE PATIENT WAS FOUND TO HAVE A METAL (COBALT CHROME) ALLERGY, AND THERE WAS A POSSIBILITY THAT THE REVISION WOULD BE PERFORMED AGAIN. AFTER THAT, THE PATIENT REQUESTED THAT THE SURGERY BE PERFORMED. REVISION THA WAS PERFORMED ON THE PATIENT. ALTHOUGH THERE WAS NO LOOSENING OR MALPOSITIONING OF THE IMPLANTS OR ANY NOTICEABLE DAMAGE, DAMAGE TO THE SOFT TISSUE (PARTICULARLY THE GLUTEUS MEDIUS MUSCLE) WAS OBSERVED. WHEN THE IMPLANTS WERE REMOVED, WHITE TISSUE WAS FOUND TO BE STUCK TO THE INNER SURFACE OF THE CUP (BETWEEN THE TRIDENT II-MDM LINER). REQUEST FROM THE DOCTOR. ALTHOUGH IT IS THOUGHT THAT THIS PHENOMENON MAY BE DUE TO AN ALLERGIC REACTION OF THE PATIENT TO THE CO-CR ALLOY IMPLANT, THE DOCTOR BELIEVES THAT THERE MAY BE OTHER FACTORS INVOLVED, AS THE SOFT TISSUE DAMAGE WAS SEVERE AND THERE WAS A LOT OF TISSUE ADHESION BETWEEN THE CUP AND LINER. THE DOCTOR HAS REQUESTED THAT STRYKER INVESTIGATE THE EXTENT AND CAUSE OF DAMAGE AND WEAR OF THE DEVICES THAT WAS REMOVED ON (B)(6)."

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Metal Related Pathology

  MAUDE report 22057199 ↗
• InjuryMay 1, 2025Degraded; Degraded

  L) HIP REVISION TODAY DUE TO SUSPECTED TRUNIONOSIS. ORIGINAL SURGERY WAS L) HIP THA ON (B)(6) 2021. REVISION TODAY IN WHICH SURGEON FOUND BLACK DEBRIS AROUND FEMORAL NECK AND GROSS SEUDO TUMOUR AROUND SITE. REPLACED FEMORAL HEAD AND LINER.

  Patient problems: Foreign Body Reaction

  MAUDE report 21940913 ↗
• InjuryMar 12, 2025Corroded; Corroded

  THE CUSTOMER REPORTED THAT: "REWORK FOR COLLECTION EVACUATION ON PTH RIGHT BRACE II EXTRA-LONG HEAD: CORROSION CONE LEVEL AL VAL TYPE PSEUDOTUMOR". CLINICAL CONSEQUENCES AND CURRENT STATUS OF THE PATIENT OR PERSON INVOLVED: CHANGE OF PTH SYNOVECTOMY BECAUSE SKIN FISTULIZATION." CORROSION, PSEUDOTUMOR, REVISION.

  Patient problems: Foreign Body Reaction

  MAUDE report 21586342 ↗
• InjuryJan 14, 2025Material Erosion; Detachment of Device or Device Component; Material Erosion; Detachment of Device or Device Component

  IT WAS REPORTED THAT ¿TRUNNIONOSIS OF HIP IMPLANT - RESULTING IN BROKEN IMPLANT NEEDING TO BE REVISED SURGICALLY¿. THIS EVENT WAS REPORTED TO STRYKER CANADA BY HEALTH CANADA VIA MANDATORY HOSPITAL REPORTING: HEALTH CANADA REFERENCE #: (B)(4).

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 21147482 ↗
• InjuryJan 14, 2025Material Erosion; Material Erosion

  IT WAS REPORTED THAT ¿TRUNNIONOSIS OF HIP IMPLANT - RESULTING IN BROKEN IMPLANT NEEDING TO BE REVISED SURGICALLY¿. THIS EVENT WAS REPORTED TO STRYKER CANADA BY HEALTH CANADA VIA MANDATORY HOSPITAL REPORTING: HEALTH CANADA REFERENCE #: (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 21147435 ↗
• InjuryJan 14, 2025Material Erosion; Detachment of Device or Device Component; Material Erosion; Detachment of Device or Device Component

  IT WAS REPORTED THAT ¿TRUNNIONOSIS OF HIP IMPLANT - RESULTING IN BROKEN IMPLANT NEEDING TO BE REVISED SURGICALLY¿. THIS EVENT WAS REPORTED TO STRYKER CANADA BY HEALTH CANADA VIA MANDATORY HOSPITAL REPORTING: HEALTH CANADA REFERENCE #: (B)(4).

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 21147434 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT THA ON (B)(6) 2012 AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE TMZF HIP STEM. HER RIGHT HIP WAS REVISED ON (B)(6) 2022 ALLEGEDLY DUE TO ELEVATED METAL IONS AND MRI FINDINGS CONSISTENT WITH ADVERSE LOCAL TISSUE REACTION.

  Patient problems: Foreign Body Reaction

  MAUDE report 21081848 ↗
• InjuryDec 10, 2024Material Erosion; Material Erosion

  IT WAS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT LEFT THA ON (B)(6) 2013 AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE II HIP STEM. SHE WAS REVISED ON (B)(6) 2022 ALLEGEDLY DUE TO INCREASING PAIN, STIFFNESS, OSTEOLYSIS AROUND THE IMPLANT WITH DESTRUCTIVE BONY EROSION, AND ELEVATED COBALT AND CHROMIUM LEVELS.

  Patient problems: Metal Related Pathology; Osteolysis; Pain

  MAUDE report 20896242 ↗
• InjuryDec 10, 2024Use of Device Problem; Use of Device Problem

  AS REPORTED VIA MEDWATCH MW5161760: A 63-YEAR-OLD FEMALE WAS BROUGHT TO THE OPERATING ROOM FOR A LEFT-SIDED HEMIARTHROPLASTY UNDER GA. THE SURGEON THEN IMPLANTED THE STRYKER OMNIFIT SIZE 6, 120MM EON C-TAPER STEM INTO THE FEMORAL CANAL. THE SURGEON THEN REQUESTED THE FEMORAL HEAD IMPLANT WITH A +2.5MM OFFSET TO PLACE ON THE IMPLANTED STEM. THE VENDOR REPRESENTATIVE WHO BROUGHT THE IMPLANTS TO THE OPERATING ROOM GAVE THE SURGEON A V40 FEMORAL HEAD WITH A 2.5MM OFFSET. THE SURGEON INSTALLED THE FEMORAL HEAD ON THE IMPLANTED STEM, TESTED THE SECURITY OF THE FIT AND PERFORMED A TRIAL REDUCTIONS AFTER APPLYING THE BIPOLAR HEAD. THE IMPLANTS WERE SECURE AND THERE WERE NO SIGNS OF INSTABILITY OF THE HIP DURING THE TRIAL REDUCTION. LATER THAT EVENING, INVESTIGATION REVEALED THAT THE STRYKER VENDOR (WHO WAS IN THE CASE) CONTACTED THE SURGEON AND NOTIFIED HIM THAT HE HAD GIVEN THE SURGEON A STRYKER V40 FEMORAL HEAD INSTEAD OF THE C-TAPER HEAD. THE V40 HEAD IS NOT COMPATIBLE WITH THE IMPLANTED STEM, AND ALTHOUGH COULD RESULT IN EARLIER FAILURE DUE TO FRETTING CORROSION AT THE MORSE TAPER CONNECTION. REVISION TO A C-TAPER HEAD TO MATCH THE STEM WAS DONE THE NEXT DAY. REVIEW OF THE TWO STRYKER

  Patient problems: Insufficient Information

  MAUDE report 20888714 ↗
• InjuryNov 20, 2024Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  IT IS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT ACETABULAR REVISION ON (B)(6) 2012 AND WAS IMPLANTED WITH AN LFIT V40 COCR FEMORAL HEAD AND COMPETITOR ACETABULAR SYSTEM. HE WAS REVISED ON (B)(6) 2021 WITH A PRE AND POST OPERATIVE DIAGNOSIS OF "MECHANICAL COMPLICATION RIGHT HIP STATUS POST RIGHT TOTAL HIP ARTHROPLASTY REVISION WITH ELEVATED COBALT AND CHROMIUM IONS AND LOOSE RIGHT FEMORAL STEM".

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 20741328 ↗
• InjuryNov 4, 2024Degraded; Degraded

  AS REPORTED: "DR. CONTACTED ME LAST NIGHT STATING THAT THIS TMZF/LFIT FEMORAL HEAD HAD TRUNNIONOSIS AND THE NECK OF THE FEMORAL STEM HAD FRACTURED. HE IS REVISING THE STEM TODAY (B)(6) 2024." RIGHT HIP. SURGEON IS INQUIRING IF ANY IMPLANTS WERE RECALLED.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 20598127 ↗

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