V40 Head 6260-9-128Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327013023), received between Jun 28, 2018 and Aug 8, 2024 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PT. CALLED AND REPORTED THAT; THE PART THAT WAS REPLACED IS NO GOOD. IT'S GIVING ME PROBLEMS. IT'S BEEN TWO OR THREE YEARS AND THE DOCTOR KEEPS JUST DENYING IT AND HE KNOWS THAT IT'S NOT RIGHT. I CAN'T EVEN WALK ON MY LEG, IT'S NUMB FROM ALL THE WAY DOWN AND I NEED SOMEBODY TO VERIFY THIS PART TO SEE IF SOME OF THESE PARKS HAVE BEEN RECALLED. I WAS TOLD TWO YEARS AGO THAT ONE OF THEM HAD BEEN RECALLED AND THIS IS STRIKER PICTURE OF THIS PART THAT I WAS TOLD THAT HAD BEEN REPLACED SEVERAL YEARS AGO. AND IT'S REFERENCE # 626-9 DASH 128 AND THE LOT NUMBER 796-0320 TO. AND IT'S THE FEMORAL HEAD LFIT 3:40 PMTM ABOVE EACH ONE OF THOSE AND IT'S STRIKERS. AND I WOULD APPRECIATE A CALL FROM SOMEBODY TO VERIFY SOMETHING ABOUT IF THIS WAS RECALLED OR HAS IT BEEN RECALLED. IT DOESN'T MATTER WHAT YEAR THIS GUY TOLD ME. IT HAD BEEN SEVERAL YEARS I THOUGHT HE SAID 2013 OR 2015, BUT I WAS SO EXCITED. I WAS SO UPSET WHEN THEY TOLD ME IT HAD BEEN RECALLED AND I JUST. I WENT TO PIECES. I NEED TO KNOW A FACT ABOUT THIS. HIP AND LEG IS SWOLLEN AND HURTS.

  Patient problems: Loss of Range of Motion; Numbness; Pain; Swelling/ Edema

  MAUDE report 19939786 ↗
• InjuryAug 19, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  BIPOLAR HEAD DISASSOCIATED FROM STEM AND FEMORAL HEAD CONSTRUCT DURING A WATER SKIING FALL. UPDATE: THE PATIENT WAS REVISED ON (B)(6) 2021.

  Patient problems: Discomfort

  MAUDE report 12344940 ↗
• MalfunctionOct 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE SALES REP THAT A CURVE METAL OBJECT WAS DETECTED THROUGH POST-OP X-RAY AND CT SCAN AFTER PATIENT WENT THROUGH A BIPOLAR HEMIARTHROPLASTY SURGERY. THE OBJECT IS LOCATING NEAR TO STRYKER UHR BIPOLAR COMPONENT AND FEMORAL METAL HEAD. PATIENT DOES NOT HAVE ANY COMPLICATION. THE OBJECT MIGHT AFFECT THE OPERATED JOINT ARTICULATION IN FUTURE. SURGICAL TEAM IS OBSERVING THE PATIENT FOR NEXT 3 MONTHS. DATE OF THE BIPOLAR HEMIARTHROPLASTY SURGERY: (B)(6) 2020 . AS PER SALES CONFIRMATION, HOSPITAL IS NOT ABLE TO PROVIDE THE ADDITIONAL INFORMATION SUCH AS X-RAY PHOTO, DUE TO PDPA IN THE COUNTRY.

  Patient problems: Insufficient Information

  MAUDE report 10703822 ↗
• InjuryMar 6, 2020Corroded; Insufficient Device Problem Information; Corroded; 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) 2011 AND HAD THE FEMORAL HEAD EXPLANTED ON (B)(6) 2018. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT IMPLANTATION AND EXPLANTATION OF THE DEVICE(S) AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

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

  MAUDE report 9799347 ↗
• InjuryOct 8, 2019Degraded; Device Dislodged or Dislocated; Degraded; Device Dislodged or Dislocated

  PATIENT PRESENTED WITH A DISLOCATED HIP AND WAS SCHEDULED FOR REVISION SURGERY ON (B)(6) 2019. UPON EXPOSURE IT WAS NOTED THAT THE POLY LINER HAD DISASSOCIATED FROM THE FEMORAL HEAD OF THE MDM CONSTRUCT. DR. MENTIONED PRIOR TO THE SURGERY THAT THE PATIENT HAD ELEVATED COBALT ION LEVELS. THE FEMORAL HEAD WAS REMOVED AND REPLACED WITH A C-TAPER ADAPTOR SLEEVE AND A +7.5 DELTA CERAMIC HEAD. THE COCR CEMENTLESS LINER WAS REMOVED AND REPLACED WITH AN X 3 0 DEGREE LINER. THERE WAS CORROSION ON THE TOP OF THE CEMENTLESS LINER. UPDATE: LEFT SIDE.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 9165811 ↗
• InjuryJun 14, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING EVENT WAS REPORTED: " INTRAPROSTHETIC DISLOCATION BETWEEN 28 MM METAL HEAD AND PE 54/28 INSERT. EQUIPMENT IMPLANTED IN (B)(6) 2017. WEAR OF THE METAL HEAD.

  Patient problems: Injury; Reaction

  MAUDE report 8699330 ↗
• InjuryMar 6, 2019Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT COCR V40 FEMORAL HEAD ON HIS LEFT HIP ON OR ABOUT (B)(6), 2013. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. PATIENT HAS NOT HAD THE FEMORAL HEAD AT ISSUE EXPLANTED.

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

  MAUDE report 8395084 ↗
• InjuryJan 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  "A FOLLOW-UP FOR HIS LEFT HIP ON (B)(6) 2013 NOTED HE COMPLAINED OF PAIN AND STIFFNESS. PHYSICAL EXAMINATION NOTED THE LEFT LEG WAS .5 CENTIMETERS SHORTER. HE WAS AMBULATING WITHOUT DEVICES OR A LIMP. A DISCUSSION WAS HAD REGARDING, "UNSURE OF ETIOLOGY OF LOSS OF MOTION AND RECURRENT PAIN AS COMPONENTS APPEAR WELL-FIXED AND WELL-PLACED".

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 8293726 ↗
• InjuryJun 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "PATIENT WAS SEEN BY ANOTHER ORTHOPAEDIC SURGEON IN (B)(6). SHE REPORTED PAIN TO THE SURGEON AND HAD LABS DRAWN. THE LABS REVEALED ELEVATED COBALT AND CHROMIUM LEVELS. THE PATIENT REPORTED THAT THE FEMORAL HEAD WAS EXCHANGED BUT NO MEDICAL RECORDS COULD BE OBTAINED BY CLINICAL STUDY STAFF. PER CONVERSATION ON 31 MAY 2018 WITH THE CLINICAL STUDY STAFF, THE PATIENT REPORTED NO PAIN IN HER REVISED HIP".

  Patient problems: Inflammation; Injury; Pain; Reaction

  MAUDE report 7647535 ↗