PROFEMUR® PHAC1254Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI M684PHAC12541), received between Jun 5, 2019 and Feb 11, 2026 — classified as 62 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (42 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 25 most recent of 63 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2026Insufficient Device Problem Information

  ALLEGEDLY, THE PATIENT ALLEGES THAT THE CONSERVE LEFT HIP PROSTHESIS IMPLANTED ON (B)(6) 2011, FAILED, REQUIRING REVISION ON (B)(6) 2024. THE PATIENT ALLEGES THAT HE EXPERIENCED PAIN AND ADVERSE LOCAL TISSUE REACTION.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 24314590 ↗
• InjurySep 27, 2024Break; Corroded; Break; Corroded

  ALLEGEDLY, FRACTURE OF THE MODULAR NECK WHILE THE PATIENT WAS PLAYING GOLF CAUSING PAIN AND LOSS OF MOBILITY. CORROSION OF THE OBLONG TAPER OF THE PROFEMUR® PLUS COCR MODULAR NECK WHERE IT SEATED IN THE POCKET OF THE STEM. NON REVISED PRODUCTS: PRODUCT ID: 73003658 LINEAGE® CERAMIC LINER 36MM X 58-62MM GROUP 3/ LOT NO.: 0311325558/ QTY: 1 PRODUCT ID: 36450058 LINEAGE® ACETABULAR SHELL 58MM SOLID HEMI FLARE STD GROUP 3/ LOT NO.: 097460688/ QTY: 1

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 20318200 ↗
• InjurySep 26, 2024Break; Break

  ALLEGEDLY, NECK FRACTURED. REVISION SURGERY IS UNKNOWN. PRODUCTS RELATED: PART: PHA00262 PROFEMUR® Z FEMORAL STEM S 21/3 TP COATED CEMENT LESS, LOT: 1498972, QTY: 1. PART: DSBFGC50 DYNASTY® BF SHELL 50MM GROUP C, LOT: 1515638 QTY: 1. PART: DLXPLC32 DYNASTY® A-CLASS® 32MM 15DG GROUP C CROSSLINKED POLY LINER, LOT: 1474637 QTY: 1.

  Patient problems: Insufficient Information

  MAUDE report 20311940 ↗
• InjuryMay 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT IS HAVING MOBILITY ISSUES.

  Patient problems: Loss of Range of Motion

  MAUDE report 19240035 ↗
• InjuryMar 21, 2024Break; Break

  ALLEGEDLY, PATIENT WAS REVISED DUE TO IMPLANT FRACTURE OF A NON-CERAMIC COMPONENT - STEM. SRNJR NUMBER: 5360046. SIDE: R. GENDER: M.

  Patient problems: Insufficient Information

  MAUDE report 18954083 ↗
• InjuryFeb 27, 2024Break; Break

  ALLEGEDLY, IMPLANT FRACTURE - STEM. SIDE: R. REVISION NJR: 4485598. GENDER: M. EXPLANTED: FEMORAL STEM, ACETABULAR CUP, MODULAR HEAD, ACETABULAR LINER.

  Patient problems: Insufficient Information

  MAUDE report 18792630 ↗
• InjuryFeb 1, 2024Break; Break

  ALLEGEDLY, THERE IS A COCR NECK FX PRE-LEGAL CLAIM. IT WAS REPORTED BY CLAIMANT?S COUNSEL THAT SHE UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2012, AND WAS IMPLANTED WITH A PROFEMUR AND COCR NECK. SHE WAS REVISED ON (B)(6) 2022, ALLEGEDLY DUE TO COCR NECK FRACTURE.

  Patient problems: Insufficient Information

  MAUDE report 18625006 ↗
• InjuryNov 16, 2023Break; Break

  ALLEGEDLY, WE INFORM YOU THAT THE MEDICAL EXPERT OPINION REQUESTED BY THE CCI ON THE PATIENT WILL TAKE PLACE ON FRIDAY, NOVEMBER 17 AT 2:30 P.M. AT THE OFFICE OF DR IN 21 BOULEVARD DEBROSSES 21000 DIJON. THE EXPERTISE CONCERNS PATIENT FOR A FRACTURE ON A MODULAR NECK. THIS EXPERTISE IS CONTRADICTORY, ALL PARTIES ARE SUMMONED. THE WRIGTH TYPE PROSTHESES, XSTEM GLADIATOR, MODULAR NECK, INSTALLED IN 2015 AT THE NANCY UNIVERSITY HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18149695 ↗
• InjuryOct 18, 2023Corroded; Corroded

  ALLEGEDLY, COCR CORROSION CLAIM (<10) LEFT.

  Patient problems: Insufficient Information

  MAUDE report 17961379 ↗
• InjuryAug 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ALLEGEDLY, UNCOUPLING OF THE FEMORAL STEM AT THE NECK (NECK-STEM JUNCTION) WITHOUT ASSOCIATED TRAUMA (UNEXPECTED RUPTURE). NEED FOR REVISION SURGERY WITH COMPLETE REPLACEMENT OF THE PROSTHETIC ASSEMBLY.

  Patient problems: Insufficient Information

  MAUDE report 17644003 ↗
• InjuryJun 12, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, SHE WAS WALKING IN (B)(6) ALBERTA WHEN THE IMPLANT FAILED, CAUSING HER TO SUSTAIN SERIOUS BODILY INJURIES. REVISION NON CONFIRMS: PRODUCT ID: PHA06208 ACETABULAR CUP "PROCOTYL® L"BEADED COATED S.48 GROUP C, LOT: 1536346, QTY: 1. PRODUCT ID: PHA04506 RIM-LOCK BIOLOX DELTA CERAMIC LINER 32 GROUP C, LOT: 15011761570070, QTY: 1. PRODUCT ID: PRGL0003 PROFEMUR® GLADIATOR® PLASMA STEM SZ 3, LOT: 1560961, QTY: 1. PRODUCT ID: 18080302 CANCELLOUS SELF-TAPPING 6.5MM BONE SCREW 2.5CM LENGTH, LOT: 15521171568961, QTY: 1.

  Patient problems: Insufficient Information

  MAUDE report 17109636 ↗
• InjuryJun 12, 2023Break; Corroded; Break; Corroded

  ALLEGEDLY, PATIENT UNDERWENT BILATERAL IMPLANTS IN 2014. THE PROFEMUR MODULAR NECK PHAC1254 COMPONENT WAS USED IN BOTH INDEX SURGERIES. HIS RIGHT-SIDED IMPLANT SNAPPED IN 2021 AND HAD A REVISION SHORTLY THEREAFTER. (RIGHT SIDE)

  Patient problems: Insufficient Information; Loss of Range of Motion; Pain

  MAUDE report 17109486 ↗
• InjuryJun 6, 2023Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  ALLEGEDLY, THE PATIENT UNDERWENT REVISION SURGERY, THE BROKEN FEMORAL STEM WAS IDENTIFIED, AND SOFT TISSUE WAS REMOVED AROUND THE FEMORAL HEAD AND IT WAS REMOVED, WE THEN REMOVED THE FEMORAL IMPLANT. WE IMPLANTED ANOTHER STEM. WE TOOK AN INTRAOPERATIVE X-RAY AND NOTED THERE WAS A PIECE OF THE DRILL BIT THAT MUST OF BROKEN DURING THE OSTEOTOMY PORTION OF THE CASE AND DISTAL ALONG THE STEM. WE THEN PLACED THE SIZE A/50 MM BODY WITH THE APPROPRIATE VERSION AND IMPACTED IT AND PLACED A LOCKING SCREW. WE THEN PLACED A 36/-6 BIOLOX HEAD AND IMPACTED. PRODUCTS NOT REVISED: PRODUCT ID: DSBFGG58, LOT: 05113366701551930, QTY: 1. PRODUCT ID: 18080303, LOT: 1543191, QTY: 1.

  Patient problems: Insufficient Information

  MAUDE report 17072760 ↗
• InjuryMay 29, 2023Break; Break

  ALLEGEDLY, ON OR ABOUT (B)(6) 2021, PATIENT RETURNED TO HIS ORTHOPEDIST AND X-RAYS OF THE RIGHT HIP REVEALED, THE STEM OF THE ARTHROPLASTY HAS FRACTURED. ON OR ABOUT (B)(6) 2021, DUE TO "FAILURE OF RECALLED HARDWARE OF THE RIGHT TOTAL HIP ARTHROPLASTY PATIENT UNDERWENT A RIGHT HIP REPLACEMENT. THE PROFEMUR® TOTAL HIP SYSTEM IMPLANTED ON PLAINTIFFS RIGHT SIDE FAILED DUE TO FRACTURE OF THE MODULAR NECK. PATIENT ORTHOPEDIC SURGEON FOUND THE "FEMORAL TRUNNION WAS FRACTURED DIRECTLY, AT THE LEVEL OF ITS INSERTION INTO THE MODULAR FEMUR." ADDITIONALLY, INTRAOPERATIVE FINDINGS REFLECT THAT PATIENT ORTHOPEDIC SURGEON MADE SEVERAL ATTEMPTS TO REMOVE THE WELL-FIXED FEMORAL STEM, AND AS SUCH SURGICAL DISSECTION, EXPOSURE, AND IMPLANT PLACEMENT TOOK TWO TIMES LONGER GIVEN THE TECHNICAL DIFFICULTY. PATIENT SURGEON FURTHER NOTED A COMBINATION OF OSTEOMAS AND BUR WERE USED TO TRY AND DISSOCIATE THE FEMORAL COMPONENT FROM THE BONE ON GROWTH. PATIENT DEVELOPED FURTHER COMPLICATIONS A RESULT OF THE REVISION SURGERY. ON OR ABOUT (B)(6) 2021, PLAINTIFF SUFFERED A RIGHT HIP DISLOCATION. ADDITIONALLY, ON OR ABOUT (B)(6) 2021, PLAINTIFF SUFFERED ANOTHER RIGHT HIP DISLOCATION.

  Patient problems: Insufficient Information

  MAUDE report 17016878 ↗
• InjuryApr 19, 2023Break; Break

  ALLEGEDLY, BROKEN MODULAR NECK. SURGERY TIME EXTENDED GREATER THAN 30 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 16768431 ↗
• InjuryJan 19, 2023Break; Noise, Audible; Break; Noise, Audible

  ALLEGEDLY, DAMAGE COMPLAINED OF BY PATIENT TO A DEFECT OF THE NON-CEMENTED WRIGHT LIMB-PROSTHESIS WITH SCREWS TO THE CUP POSITIONED ON THE RIGHT HIP. INFORMATION RECEIVED STATED "REGARDING THE BREAKDOWN OF SAID DEVICE". NO INFORMATION WAS RECEIVED ABOUT PARTS AND LOT NUMBERS. NO SURGERY/INCIDENT DATES WERE PROVIDED. IT HAS NOT BEEN INDICATED IF A REVISION SURGERY HAS OCCURRED. ADDITIONAL INFORMATION RECEIVED ON 09/27/2022: ALLEGEDLY, PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2011 WITH THE DIAGNOSIS OF RIGHT COXARTHROSIS ON OUTCOMES OF DYSPLASIA. ON (B)(6) 2011 HE UNDERWENT RIGHT HIP ARTHROPLASTY. IT DOES NOT APPEAR THAT THE PATIENT SUFFERED ANY PARTICULAR PROBLEMS AFFECTING HIS RIGHT HIP IN THE FOLLOWING YEARS. ON (B)(6) 2019 THE PATIENT WHILE WALKING ACCUSED A STRONG AND SUDDEN PAIN WITH FUNCTIONAL IMPOTENCE OF THE RIGHT HIP. IT IS STATED THAT THERE WAS ALSO A CRACKING NOISE. VISITED THE U.O.C AND RADIOGRAPHS OF THE RIGHT HIP WERE TAKEN. A DIAGNOSIS OF FRACTURED COLLAR OF THE RIGHT HIP PROSTHESES WAS MADE. ON (B)(6) 2019 THE PATIENT UNDERWENT AN OPERATION TO REMOVE THE BROKEN PROSTHESIS AND REPROTHESIS OF THE RIGHT HIP THROUGH A TRANSFEMORAL ROUTE. THE POST-OPERATIVE COURSE WAS R

  Patient problems: Pain

  MAUDE report 16208077 ↗
• InjuryOct 12, 2022Break; Break

  ALLEGEDLY, AFTER GETTING UP WITH NORMAL EXERTION, THE MODULAR NECK BROKE OFF.

  Patient problems: Failure of Implant

  MAUDE report 15589612 ↗
• InjuryJul 19, 2022Device Dislodged or Dislocated

  ALLEGEDLY, THE CT REPORT ON (B)(6) 2021 SHOWS A DISLOCATION OF THE ACETABULAR PART OF THE HIP ENDOPROSTHESIS, OSTEOLYSIS AND PAIN. THE SAME RESULT ALSO SHOWS THAT OLDER RADIOGRAPHS SHOW A SIGNIFICANT REACTION IN THE AREA OF THE LEFT HIP WITH LAYERS ALONG THE LEFT HIP PROSTHESIS. PX PERFORMED AN X-RAY ON (B)(6) 2021 AND THE RESULTS SHOW THAT THERE WAS THINNING OF THE BONE IN THE ACETABULAR PART OF THE ENDOPROSTHESIS AND IN THE FEMUR. LOSS OF MOBILITY DUE TO PAIN. PRODUCTS NOT REVISED, ALLEGEDLY REVISION SURGERY SCHEDULED FOR (B)(6) 2022.

  Patient problems: Metal Related Pathology; Osteolysis; Pain

  MAUDE report 15051564 ↗
• InjuryJun 27, 2022Break; Break

  ALLEGEDLY, PX WAS ADMITTED TO HOSPITAL AFTER HE FELL AT HOME AND THE X-RAYS SHOWED THE IMPLANT FRACTURE. SURGEON DOES NOT KNOW HOW HE CAME TO FELL I.E. IF HE STUMBLED AND FELL OR IF THE IMPLANT FAILED AND HE FELL BECAUSE OF THAT. A REVISION SURGERY WAS REQUIRED TO MAKE A STEM CHANGE. BFARM CASE NUMBER: (B)(4).

  Patient problems: Fall

  MAUDE report 14835696 ↗
• InjuryJun 24, 2022Break; Break

  ALLEGEDLY, BROKEN MODULAR NECK LONG VAR/VAR 15º ON A PROFEMUR PRESERVE STEM. SURGERY TIME EXTENDED GREATER THAN 30 MINUTES. COMPONENTS NOT REVISED: 1- PHA06212, PROCOTYL L ACETABULAR SHELL SIZE 52, LOT: 1593577, QTY:1. 2- PHA04510, RIM LOCK BIOLOX DELTA LINER GROUP E, LOT: 1597371, QTY:1.

  Patient problems: Insufficient Information

  MAUDE report 14800850 ↗
• InjuryJun 14, 2022Corroded; Material Frayed; Corroded; Material Frayed

  ALLEGEDLY, DEVICE IMPLANTED IN RIGHT SIDE FAILED DUE TO MICRO-MOTION, FRETTING AND CORROSION, CREATING PAIN AND PHYSICAL IMPAIRMENT. ALL PRODUCTS REVISED.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 14690822 ↗
• InjuryJun 13, 2022Corroded; Corroded

  ALLEGEDLY, DEVICE IMPLANTED IN RIGHT SIDE FAILED DUE TO MICRO-MOTION, FRETTING AND CORROSION, CREATING PAIN AND PHYSICAL IMPAIRMENT. ALL PRODUCTS REVISED.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 14675027 ↗
• InjuryMar 8, 2022Break; Break

  ALLEGEDLY, THE PATIENT REPORTED SUDDEN PAIN IN THE RIGHT HIP AND INABILITY TO EXERCISE WHEN GETTING UP FROM A SITTING POSITION. X-RAY EVIDENCE OF THE CONE FRACTURE. BFARM CASE NUMBER: (B)(4).

  Patient problems: Pain

  MAUDE report 13693884 ↗
• InjuryFeb 24, 2022Break; Break

  ALLEGEDLY, PATIENT WAS REVISED DUE TO IMPLANT FRACTURE - STEM REVISION NJR NUMBER: (B)(4). SIDE:L. PRIMARY ASA: FIT AND HEALTHY. COMPONENTS FROM OTHER MANUFACTURER THAT WERE REVISED: CENATOR CUP 28X48 NEUT LGE FLG PRODUCT ID: 176848/ LOT NO.: 306444.

  Patient problems: Failure of Implant

  MAUDE report 13590538 ↗
• InjuryJan 11, 2022Break; Break

  ALLEGEDLY, THE PATIENT FELT A BURST IN HIS HIP AND FELL. BROKEN NECK.

  Patient problems: Fall

  MAUDE report 13225841 ↗