V40 Head 6260-9-328Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327013115), received between Oct 4, 2018 and Dec 22, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryOct 26, 2023Material Erosion; Material Erosion

  IT IS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT A RTHA ON (B)(6) 2013 WHERE A CITATION TMZF HIP STEM AND A LFIT V40 FEMORAL HEAD WERE IMPLANTED. ALLEGEDLY SHE WAS REVISED ON (B)(6) 2020 DUE TO PAIN, ELEVATED COBALT AND CHROME LEVELS, AND PSEUDOTUMOR.

  Patient problems: Metal Related Pathology

  MAUDE report 18009642 ↗
• InjuryAug 1, 2022Degraded; Degraded

  IT WAS REPORTED THROUGH COUNSEL THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY AND WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD AND WAS REVISED DUE TO ALLEGED PSEUDOTUMOR AND TRUNNIONOSIS.

  Patient problems: Cancer

  MAUDE report 15137411 ↗
• InjuryJan 12, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISSOCIATION OF THE FEMORAL HEAD FROM THE POLY INSERT, AND DISLOCATION OF THE POLY INSERT FROM THE METAL LINER. PATIENT WAS REVISED FROM A 28MM + 8 LFIT FEMORAL HEAD AND RESTORATION X3 INSERT TO NEW DEVICES OF THE SAME TYPE AND SIZE. REP WILL BE PROVIDING PICTURES AND XRAYS.

  Patient problems: Joint Dislocation

  MAUDE report 11156402 ↗
• InjuryMar 8, 2019Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  IT WAS REPORTED THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HER LEFT HIP ON OR ABOUT (B)(6) 2008 AND WAS REVISED ON (B)(6) 2018. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD. UPDATE PER MEDICAL RECORDS RECEIVED FROM LEGAL 03-OCT-2023: "PRE-OP DIAGNOSIS: PAINFUL LEFT TOTAL HIP ARTHROPLASTY WITH A RECALLED IMPLANT. POST-OP DIAGNOSIS: ____ OF THE LEFT TOTAL HIP ARTHROPLASTY WITH WEAR IN THE METAL HEAD AND NECK AREA. ... METALOSIS AROUND THE HEAD AND NECK AREA WITH BLACK METAL DEBRIS AROUND THE AREA. AT THIS POINT, THE STEM WAS REMOVED USING A COMBINATION OF OSTEOTOMES AND DISIMPACTORS, WHICH WAS REMOVED UNEVENTFULLY WITH MINIMAL CLEAR SPLITTING WITH THE OSTEOTOME."

  Patient problems: Inflammation; Injury; Metal Related Pathology; Reaction

  MAUDE report 8406063 ↗
• InjuryJan 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE ATTORNEY THAT PLAINTIFF UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. HEAD WAS REVISED ON (B)(6) 2011. THIS PI IS FOR HEAD REVISION 1.

  Patient problems: Injury

  MAUDE report 8272254 ↗
• InjuryJan 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE ATTORNEY THAT PLAINTIFF UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. HEAD WAS REVISED ON (B)(6) 2011 AND ONCE AGAIN ON (B)(6) 2011. *THIS PI IS FOR HEAD REVISION 2.

  Patient problems: Injury

  MAUDE report 8272252 ↗
• InjuryNov 29, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISLOCATION OF THE STRYKER HEAD FROM A COMPETITOR LINER.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8115672 ↗
• InjuryOct 4, 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 HER RIGHT HIP ON OR ABOUT (B)(6) 2006 AND WAS REVISED ON (B)(6) 2016. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL, EXCESSIVE LEVELS OF COBALT AND CHROMIUM IN HIS BLOOD.

  Patient problems: Injury; Reaction

  MAUDE report 7935204 ↗