PROFEMUR® PHAC1204Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI M684PHAC12041), received between May 30, 2019 and Oct 3, 2024 — classified as 23 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 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.

• InjuryOct 3, 2024Peeled/Delaminated; Insufficient Device Problem Information; Peeled/Delaminated; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT UNDERWENT REVISION SURGERY ON RIGHT HIP DUE TO PAIN, A SUBSEQUENT MRI WHICH REVEALED SIGNIFICANT METALLOSIS AS WELL AS PSEUDOTUMOR FOUNDED, THE CAPSULE AND SHORT EXTERNAL ROTATORS WERE NOT ATTACHED TO THE POSTERIOR TROCHANTER, THERE WAS A SIGNIFICANT METALLOSIS OF THE TRUNNION OF THE DUAL MODULAR NECK AS WELL AS THE INNER PORTION OF THE HEAD AND AT THE JUNCTION OF THE NECK AND STEM ON BOTH SIDED OF THE TAPER.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 20363673 ↗
• InjuryFeb 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, REVISION DONE DUE TO PAINFUL HIP. THEY TOOK OUT THE STEM, NECK, HEAD AND POLY. THEY REPLACE THE POLY. PRODUCTS NO REVISE: PRODUCT: DSBFGD52 DYNASTY® BF SHELL 52MM GROUP D, LOT: 1502022, QTY: 1

  Patient problems: Pain

  MAUDE report 18686392 ↗
• InjuryJan 24, 2024Break; Crack; Break; Crack

  ALLEGEDLY, THE PATIENT BENT OVER AND FELT A CRACKING SENSATION IN HIS LEFT HIP AND A SAGGING OF HIS LEFT LEG. ADDITIONAL INFORMATION RECEIVED ON 12-20-2023: REVISION DUE TO BROKEN NECK. ADDITIONAL INFORMATION RECEIVED ON 05-21-2024: BFARM SENDS THE IMPLANT CARD WITH ALL THE PRODUCTS. NON REVISED PRODUCTS: PRODUCT ID: PRGLHA07 PROFEMUR® GLADIATOR® HA STEM W/ COLLAR SZ 7/ LOT NUMBER: 1595955/ QTY: 1. PRODUCT ID: PHA04614 RIM-LOCK "A-CLASS®" ACETABULAR POLY LINER 0° SIZE 36 GROUP G/ LOT NUMBER: 15460181567319/ QTY: 1. PRODUCT ID: PHA06222 ACETABULAR CUP "PROCOTYL® L" BEADED COATED S.62 GROUP G/ LOT NUMBER: 078587711/ QTY: 1.

  Patient problems: Insufficient Information

  MAUDE report 18573279 ↗
• MalfunctionOct 18, 2023Corroded; Corroded

  ALLEGEDLY, COCR CORROSION CLAIM (10+). LEFT SIDE.

  Patient problems: Insufficient Information

  MAUDE report 17959795 ↗
• InjuryJun 2, 2023Corroded; Corroded

  ALLEGEDLY, COMPONENTS REVISED DUE TO CORROSION.

  Patient problems: Insufficient Information

  MAUDE report 17049571 ↗
• InjuryJan 2, 2023Corroded; Material Frayed; Corroded; Material Frayed

  ALLEGEDLY, ON (B)(6) 2010, PATIENT HAD A WRIGHT MEDICAL PROFEMUR R BOWED DISTAL STEM AND PROXIMAL BODY, MATED WITH A PROFEMUR PLUS COCR MODULAR NECK, IMPLANTED IN HIS LEFT HIP. ON (B)(6) 2020, PATIENT'S PROFEMUR R BOWED DISTAL STEM SUDDENLY AND WITHOUT WARNING FAILED, FRACTURING IN TWO NEAR THE TOP OF THE STEM, BELOW THE MORSE TAPER. ON (B)(6) 2020, PATIENT HAD A REVISION SURGERY PERFORMED ON HIS LEFT. IN THE COURSE OF THE (B)(6) 2020, REVISION SURGERY THE DOCTOR NOTED THAT THE PROXIMAL BODY AND HEAD WERE GROSSLY LOOSE AND WERE EXTRACTED BY HAND. SURGEON PERFORMED AN EXTENDED TROCHANTERIC OSTEOTOMY TO REMOVE THE DISTAL REMNANT OF THE FRACTURED PROFEMUR R BOWED DISTAL STEM. IN THE (B)(6) 2020, REVISION SURGERY THE WRIGHT MEDICAL PROFEMUR R BOWED DISTAL STEM, PROFEMUR PROXIMAL BODY, PROFEMUR PLUS COCR MODULAR NECK, AND CERAMIC FEMORAL HEAD WERE REMOVED FROM THE BODY OF THE PATIENT, AND REPLACED WITH STRYKER ARTIFICIAL DEVICES, INCLUDING A STRYKER RESTORATION MODULAR SIZE 15 195MM CURVED STEM, 25MM +0 PROXIMAL BODY AND A 32MM +4 DELTA CERAMIC HEAD. IN THE COURSE OF THE (B)(6) 2020, REVISION SURGERY DOCTOR FOUND THE ACETABULAR COMPONENT (THE CUP) TO BE WELL FIXED WITH A CERAMIC LINER A

  Patient problems: Metal Related Pathology; Nerve Damage; Pain

  MAUDE report 16083146 ↗
• InjuryJul 5, 2022Corroded; Corroded

  ALLEGEDLY, THE PATIENT PRESENTED CORROSION.

  Patient problems: Insufficient Information

  MAUDE report 14916760 ↗
• InjuryMay 12, 2022Material Discolored

  ALLEGEDLY, THE PATIENT HAS BEEN SUFFERING MODERATE PAIN, AND THE IMPLANTS WERE REVISED FOR METALLOSIS, ACCORDING TO THE SURGEON. THE MODULAR NECK TRUNION (FITTING IN TO THE STEM POCKET) WAS NOTICEABLY "BLACKENED". ALL IMPLANTS WERE REMOVED, AND REPLACED WITH A THR CEMENT SPACER. UNFORTUNATELY IT WASN'T POSSIBLE TO REMOVE THE LINER FROM THE PROCOTYL L SHELL, SO I CANT PROVIDE THE LOT NUMBER FOR THE BIOLOX LINER.

  Patient problems: Metal Related Pathology; Pain; Unspecified Infection

  MAUDE report 14378126 ↗
• InjuryMar 1, 2022Break

  ALLEGEDLY, PATIENT WAS EX DOMO (PROF R IMPLANTATION IN ANOTHER HOSPITAL). PROSTHESIS PSEUDO- ARTHRITIC, BROKEN STEM BELOW PROXIMAL PART. REGARDING A LOW GRADE INFECT AS DIFFERENTIAL DIAGNOSIS, STEM AND CUP EXPLANTED IN (B)(6) HOSPITAL. BFARM CASE NUMBER: (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 13640043 ↗
• InjuryDec 10, 2021Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, PROSTHESIS REVISION FOR SEPSIS.

  Patient problems: Unspecified Infection

  MAUDE report 12975830 ↗
• InjuryJul 13, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DO TO UNKNOWN REASONS, AFTER A RIGHT TOTAL HIP ARTHROPLASTY.

  Patient problems: Insufficient Information

  MAUDE report 12158421 ↗
• InjuryJun 25, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SAE # (B)(6): ALLEGEDLY, THE PATIENT HAD A LUXATION OF THE RIGHT HIP WITH PERIPROSTHETIC FRACTURE. JOINT REDUCTION PERFORMED ON (B)(6) 2017. SAE # (B)(4): ALLEGEDLY, PATIENT SAT ON THE SOFA. WHEN LIFTING THE RIGHT LEG, THE HIP LUXATED. RECOVERED AFTER REMOVING HEAD AND MODULAR NECK OF THE RIGHT HIP. BFARM CASE NUMBER: (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12071473 ↗
• InjuryMay 12, 2021Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS :(B)(4). SIDE:R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. COMPONENT NOT REVISED: PROCOTYL L BEADED AND HA COATED CUP SIZE 50MM PRODUCT ID: PHA06260 LOT NO.: 1407207 RIM-LOCK BIOLOX DELTA CERAMIC LINER 32MM ID GROUP D PRODUCT ID: PHA04508 LOT NO.: 601164314 (B)(6) REFERENCE NO: (B)(4).

  Patient problems: Metal Related Pathology

  MAUDE report 11813183 ↗
• InjuryJan 28, 2021Corroded; Corroded

  ALLEGEDLY, THE PATIENT WAS REVISED AS A RESULT OF PAIN, ELEVATED COBALT AND CHROMIUM LEVELS, AND A LARGE PSEUDOTUMOR DUE TO THE FAILED METAL-METAL JUNCTION CORROSION AT THE COCR MODULAR NECK AND THE TITANIUM STEM. EXCLUDING THE ISSUES CONCERNING CORROSION OF THE MODULAR NECK, THE PATIENT'S HIP REPLACEMENT WAS NOT OTHERWISE IN NEED OF A HIP REVISION SURGERY.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 11243402 ↗
• InjuryNov 10, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS REVISION NJR NUMBER: (B)(4), SIDE: R, PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING, MHRA REFERENCE NO: (B)(4).

  Patient problems: Metal Related Pathology

  MAUDE report 10817692 ↗
• InjuryOct 16, 2020Device Dislodged or Dislocated

  FIRST INFORMATION RECEIPT ON (B)(6) 2020: PATIENT'S WIFE CALLED (B)(6) TO REPORT THAT HER HUSBAND HAD A REVISION SURGERY. NEW INFORMATION RECEIPT ON (B)(6) 2020: ALLEGEDLY, THE PRODUCT WAS DISLODGED BUT THAT THERE WAS METALLOSIS. STILL PENDING TO CONFIRM IF THE HIP IMPLANT WAS MANUFACTURED BY MICROPORT OR ANOTHER COMPANY. APPARENTLY, AT THE REVISION THEY USED A MICROPORT PRODUCT.

  Patient problems: No Information

  MAUDE report 10689415 ↗
• InjurySep 21, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, THE PATIENT HAD DISLOCATION OUT FRONT. LINER, HEAD AND NECK WERE REPLACED. THIS IS THIS PATIENT'S SECOND REVISION, AND THE FIRST REVISION WAS CAPTURED UNDER INCIDENT GROUP: (B)(4).

  Patient problems: Joint Dislocation

  MAUDE report 10563972 ↗
• InjuryAug 5, 2020Corroded; Material Disintegration; Corroded; Material Disintegration

  ALLEGEDLY, PATIENT WAS REVISED DUE TO CORROSION AT THE METAL-METAL JUNCTION ISSUE AT THE COCR MODULAR NECK AND TITANIUM STEM. IN THE REVISION OPERATIVE REPORT, DR. (B)(6) NOTED "THERE WAS SIGNIFICANT METALLOSIS THROUGHOUT THE HIP SYNOVIUM."

  Patient problems: Toxicity

  MAUDE report 10371145 ↗
• InjuryMay 19, 2020Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, REVISED DUE TO TOTAL ASEPTIC LOOSENING.

  Patient problems: No Information

  MAUDE report 10072173 ↗
• InjuryJan 29, 2020Material Disintegration; Insufficient Device Problem Information; Material Disintegration; Insufficient Device Problem Information

  ALLEGEDLY, MOM HEAD WAS EXPLANTED AND SWAPPED FOR OUR 28MM LONG CERAMIC AND STRYKERS DUAL MOBILITY LINER.

  Patient problems: Reaction

  MAUDE report 9642464 ↗
• InjuryOct 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY THE PATIENT WAS REVISED DUE TO MOM COMPLICATIONS: HIGH COCR ION LEVELS. LEFT HIP.

  Patient problems: Metal Related Pathology; Reaction

  MAUDE report 9150827 ↗
• InjuryAug 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS.

  Patient problems: No Information

  MAUDE report 8927773 ↗
• InjuryJun 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING SOCKET; PAIN. MICROPORT HEAD, NECK AND STEM WERE IMPLANTED WITH A COMPETITOR'S SHELL AND LINER. SRNJR NUMBER: (B)(6). SIDE: L. FRASA: P3 INCAPACITATING SYSTEMATIC DISEASE. THE FOLLOWING COMPONENT HAVE NO ALLEGED DEFICIENCY AND WERE NOT REVISED DURING THIS SURGERY: PROFEMUR® L HIP STEM SIZE 2 HA COATED PHA05504 LOT # 1526066 QTY. 1.

  Patient problems: Pain

  MAUDE report 8732927 ↗
• InjuryMay 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Unspecified Infection

  MAUDE report 8656097 ↗