Profemur PHA01252Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI M684PHA012521), received between Jan 29, 2020 and Nov 1, 2024 — classified as 24 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryNov 1, 2024Break; Naturally Worn; Break; Naturally Worn

  ALLEGEDLY, DURING REVISION OF A PATIENT WITH A THA REPLACEMENT IN 2011, A LINER AND NECK FRACTURE WERE IDENTIFIED. THE NECK WAS CONFIRMED ON PREOPERATIVE CT AND THE LINER WAS FOUND TO HAVE BEEN DAMAGED INTRAOPERATIVELY. THE LINER WAS DAMAGED BECAUSE IT PROTRUDED FROM THE CUP. AS FOR THE NECK, IT IS NECESSARY TO INVESTIGATE THE POSSIBILITY OF INTERNAL DAMAGE. JAPAN (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20588231 ↗
• InjuryOct 31, 2024Corroded; Corroded

  ALLEGEDLY, POSSIBLE REVISION DUE TO PAIN AND CORROSION.

  Patient problems: Pain

  MAUDE report 20578359 ↗
• InjuryOct 23, 2023Break; Break

  ALLEGEDLY, TI NECK FX CLAIM (10+). RIGHT.

  Patient problems: Insufficient Information

  MAUDE report 17985072 ↗
• InjuryDec 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ALLEGEDLY, TROUBLESHOOTING SITUATION: X-RAY WAS TAKEN DUE TO THE PATIENT'S COMPLAINT OF DISCOMFORT, AND IT WAS FOUND THAT THE PATIENT HAD DISLOCATED. NEXT DAY, REVISION OF NECK, HEAD, AND BIPOLAR CUP REPLACEMENT WAS PERFORMED. PHYSICIAN'S FINDINGS: THE PATIENT'S FALL CAUSED A STRONG IMPACT, AND HE SUSPECTED THAT THE NECK AND BIPOLAR CUP WERE DISLOCATED DUE TO IMPINGEMENT. HE ALSO SPECULATED THAT THERE IS NO DOUBT THAT THERE IS ALSO A WOUND ON THE IMPLANT THAT WAS REMOVED. (B)(4).

  Patient problems: Discomfort; Fall

  MAUDE report 16047653 ↗
• InjuryAug 10, 2022Corroded; Unstable; Device Dislodged or Dislocated; Corroded; Unstable; Device Dislodged or Dislocated

  ALLEGEDLY, ON OR ABOUT APRIL 30, 2014 PATIENT HAD A PROFEMUR TOTAL HIP SYSTEM IMPLANTED IN HER RIGHT HIP. ON OR ABOUT (B)(6) 2019 PATIENT REPORTED FOR REVISION SURGERY DUE TO ELEVATED COBALT AND CHROMIUM LEVELS, PAIN AND EVIDENCE OF A PSEUDOTUMOR. PATIENT'S FIRST REVISION WAS NECESSARY BECAUSE THE DEVICE FAILED DUE TO CORROSION AT THE NECK-STEM JUNCTION. IT WAS DISCOVERED CORROSION OF THE PROFEMUR COCR MODULAR NECK WHERE IT SEATED IN THE POCKET OF THE MODULAR STEM. THE IMPLANTED NECK AND HEAD WERE REVISED. AFTER THE REVISION SURGERY PATIENT REPORTED AT LEAST 3 DISLOCATIONS. THE PREVIOUS EVENTS WERE CAPTURED UNDER MICROPORT ORTHOPEDICS GROUP NUMBER: (B)(4). ADDITIONAL INFORMATION RECEIVED 7/21/2022: ALLEGEDLY, ON OR ABOUT (B)(6) 2021, PATIENT REPORTED FOR A REVISION SURGERY OF THE RIGHT TOTAL HIP ARTHROPLASTY, REVISION OF BOTH THE ACETABULAR AND FEMORAL COMPONENTS. SURGEON RECOMMENDED THIS SECOND REVISION SURGERY DUE TO RECURRENT INSTABILITY WITH DISLOCATIONS. DURING REVISION SURGERY, SURGEON DETERMINED THE ONLY WAY TO SAFELY REMOVE THE MODULAR STEM WAS TO PERFORM AN EXTENDED TROCHANTERIC OSTEOTOMY (ETO), WHICH REQUIRED FOUR DALL MILES CABLES WITH THE USE OF A 240 MM REVISION STEM.

  Patient problems: Metal Related Pathology; Osteopenia/ Osteoporosis

  MAUDE report 15199771 ↗
• InjuryMay 11, 2022Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, IN THE REVISION SURGERY THE DR NOTED THAT THERE WAS A LARGE SOFT TISSUE MASS (PSEUDOTUMOR) IN THE POSTERIOR ASPECT OF THE HIP CAPSULE AND EXTERNAL ROTATORS ADDITIONAL THAT THERE WAS A SIGNIFICANT AMOUNT OF METAL-STAINED TISSUE INVOLVING SYNOVIUM, CAPSULE AND BONE IN BOTH, FEMUR AND ACETABULUM, THAT HE REMOVED AN EXCESSIVE AMOUNT OF MEMBRANES, METALLOSIS AND OSTEOLYTIC SOFT TISSUE. BECAUSE THE HIP STEM WAS WELL FIXED, AN EXTENDED TROCHANTERIC OSTEOTOMY WAS REQUIRED TO REMOVE THE PROFEMUR® PLASMA Z STEM IN PLAINTIFF'S LEFT HIP AND REMOVED ALL OF THE WRIGHT MEDICAL DEVICES THAT HAD BEEN IMPLANTED IN PLAINTIFF'S LEFT HIP, EXCEPT FOR THE CONSERVE® PLUS SPIKED CUP, WHICH WAS WELL FIXED AND LEFT IN PLACE. IN (B)(6) 2021 PLAINTIFF DEVELOPED ADVERSE SYMPTOMS INCLUDING, BUT NOT LIMITED TO, PROGRESSIVELY WORSENING PAIN IN AND AROUND HIS HIP JOINTS. IN (B)(6) 2021 AN MRI DEMONSTRATED LARGE FLUID FILLED COLLECTIONS OVER BOTH OF PLAINTIFF'S HIPS. IN (B)(6) 2021 LABORATORY TESTS ALSO REVEALED THAT PLAINTIFFS COBALT AND CHROMIUM LEVELS IN HIS BLOOD WERE SIGNIFICANTLY ELEVATED.

  Patient problems: Metal Related Pathology; Osteolysis

  MAUDE report 14361749 ↗
• InjuryApr 1, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO DISLOCATION/SUBLUXATION COMPONENTS NOT REVISED : PRODUCT ID: PHA06262 / PROCOTYL L BEADED AND HA COATED CUP SIZE 52MM / LOT# 58567095. PRODUCT ID: PPR67604/ ANCA-FIT HA COATED ANATOMIC FEMORAL STEM SIZE 11 RIGHT / LOT# 28531335 REVISION NJR NUMBER: 4785509. SIDE:R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Insufficient Information

  MAUDE report 13979752 ↗
• InjuryAug 24, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO DISLOCATION. THE BIPOLAR CUP FELL OFF THE HEAD. T WAS CONFIRMED THAT THE SOFT TISSUE WAS WRAPPED AROUND THE RING PART IN THE TUMBLED BIPOLAR CUP. (B)(4).

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 12360129 ↗
• InjuryJul 28, 2021Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. REVISION NJR NUMBER: (B)(4). SIDE:L. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Unspecified Infection

  MAUDE report 12241324 ↗
• InjuryJun 22, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO DISLOCATION. (B)(4).

  Patient problems: Joint Dislocation

  MAUDE report 12040101 ↗
• InjuryDec 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO UNKNOWN REASONS.

  Patient problems: Insufficient Information

  MAUDE report 11076816 ↗
• InjurySep 7, 2020Use of Device Problem; Device Dislodged or Dislocated; Use of Device Problem; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS SQUATTING WHICH LEAD OUT A LUXATION OF THE IMPLANTED HIP; LATER IT COULD BE REPOSITIONED BY CLOSED REPOSITION.

  Patient problems: No Information

  MAUDE report 10499531 ↗
• InjuryAug 27, 2020Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PAIN WITHOUT LOOSENING COMPONENTS NOT REVISED: COTYLE "ANCA" AVEC TROUS A/REVET. HAP 50, PPR67250, LOT V0288744. TIGE "ANCA FIT?" REV. HAP 1/3 PROXIMAL 14D, PPR67616, LOT V04185939. INSERT CERAM "ANCA FIT?" 28/40 50-52-54/28 AL2.O3 BIO. FORTE, PPR67510, LOT U10129286.

  Patient problems: Pain

  MAUDE report 10460349 ↗
• InjuryJul 31, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PROSTHESIS DISLOCATION. COMPONENTS NOT REVISED: PPR67614 TIGE "ANCA FIT?" REV. HAP 1/3 PROXIMAL 13G T07125201M PPR67254 COTYLE "ANCA" AVEC TROUS A/REVET. HAP 54 T06123349.

  Patient problems: No Information

  MAUDE report 10351265 ↗
• InjuryJul 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PROSTHESIS DISLOCATION COMPONENT NOT REVISED: TIGE "ANCA FIT?" REV. HAP 1/3 PROXIMAL 15D PPR67620, LOT U0780691.

  Patient problems: No Information

  MAUDE report 10230352 ↗
• InjuryMay 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO UNKNOWN.

  Patient problems: No Information

  MAUDE report 10092866 ↗
• InjuryApr 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO UNKNOWN REASONS.

  Patient problems: No Information

  MAUDE report 9916563 ↗
• InjuryMar 31, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO UNKNOWN REASONS.

  Patient problems: No Information

  MAUDE report 9904558 ↗
• InjuryMar 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO UNKNOWN REASONS.

  Patient problems: No Information

  MAUDE report 9874343 ↗
• InjuryMar 10, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, SUBJECT WAS SEEN IN EMERGENCY ROOM WITH RIGHT HIP PAIN FOR 2 WEEKS, CRUNCHING WITH MOTION AND DIFFICULTY AMBULATING. LINER FRACTURE WAS CONFIRMED BY X RAY AND CT OF THE HIP. SUBJECT HAD A REVISION AND REMOVAL OF THE ORIGINAL ACETABULAR, LINER, MODULAR NECK AND FEMORAL HEAD AND WAS DISCHARGED ON (B)(6) 2015.

  Patient problems: Pain

  MAUDE report 9813752 ↗
• InjuryFeb 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO UNKNOWN. COMPONENTS NOT REVISED ": COTYLE "ANCA" AVEC TROUS A/REVET. HAP 54 PPR67254 T01116705 INSERT CERAM ANCAFIT 28/40 50-52-54/28 PPR67510.

  Patient problems: No Information

  MAUDE report 9727607 ↗
• InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, PATIENT WAS REVISED DUE TO UNKNOWN.

  Patient problems: No Information

  MAUDE report 9727448 ↗
• InjuryJan 29, 2020Material Disintegration; Material Disintegration

  ALLEGEDLY, PATIENT UNDERWENT A REVISION SURGERY OF HER FAILED RIGHT TOTAL HIP ARTHROPLASTY SECONDARY TO METAL WEAR DEBRIS BETWEEN MODULAR COMPONENTS. PATIENT SUFFERED PERSISTENT PAIN, SWELLING, ELEVATED METAL IONS IN THE BLOODSTREAM, LOSS OF MOBILITY, AND DISCOMFORT.

  Patient problems: Loss of Range of Motion; Pain; Swelling

  MAUDE report 9645199 ↗
• InjuryJan 29, 2020Break; Break

  ALLEGEDLY, PATIENT WAS REVISED DUE TO BREAKAGE OF IMPLANT. (B)(4).

  Patient problems: No Information

  MAUDE report 9643018 ↗