Profemur PHA01204Recalls & reported problems
Microport Orthopedics Inc. · PROFEMUR NECK NEUTRAL LONG · Class 3 · Implant
Quick summary
This MicroPort Orthopedics Profemur hip implant is a metal-on-ceramic artificial hip joint used in total hip replacement. The 32 adverse event reports mostly describe the modular neck breaking or snapping, sometimes while patients were walking or standing, along with hip dislocation, corrosion at the neck junction, and difficulty removing components during revision surgery. Reports mention 31 injuries and no deaths, with patients reporting pain, sudden inability to bear weight, and in some cases high metal ion levels. No recalls name this device, and reports have slowed in the past year.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 31
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI M684PHA012041), received between Jul 24, 2019 and Nov 19, 2024 — classified as 31 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (21 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.
Reports received per month
Most reported problems
Device problems
- Break21
- Insufficient Device Problem Information5
- Corroded2
- Device Dislodged or Dislocated2
- Difficult to Remove2
- Adverse Event Without Identified Device or Use Problem1
- Collapse1
Patient problems
- No Information12
- Pain5
- Insufficient Information4
- No Code Available3
- Unspecified Infection2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Bone Fracture(s)1
- Discomfort1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
InjuryNov 19, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, ALL COMPONENTS WERE REMOVED FROM THE FEMUR. THE CANAL WAS COPIOUSLY IRRIGATED. THE FINAL COMPONENTS WERE IMPACTED INTO PLACE. THE HIP WAS AGAIN RELOCATED AND NOTED TO HAVE EXCELLENT RANGE OF MOTION AND EXCELLENT STABILITY. 66-YEAR-OLD MALE WITH A HISTORY OF A RIGHT TOTAL HIP ARTHROPLASTY DONE IN 2009 AND PREVIOUSLY WELL-FUNCTIONING PRESENTED TO MY OFFICE EARLIER THIS WEEK WITH 2 WEEKS OF INABILITY TO BEAR WEIGHT AND EXCRUCIATING PAIN IN THE RIGHT HIP. X-RAYS REVEAL A CATASTROPHICALLY FAILED RIGHT TOTAL HIP ARTHROPLASTY WITH A FRACTURE THROUGH THE DUAL MODULAR NECK. X-RAYS REVEAL A CATASTROPHICALLY FAILED RIGHT TOTAL HIP ARTHROPLASTY WITH A FRACTURE THROUGH THE DUAL MODULAR NECK. PATIENT HAD INFLAMMATORY MARKERS AS WELL AS AN ASPIRATION THAT WAS NONCONCERNING FOR INFECTION. WE IMMEDIATELY ENCOUNTERED THE BROKEN NECK SEGMENT AS WELL AS METALLOSIS WITHIN THE JOINT CAPSULE. THIS WAS EXCISED AND DEBRIDED. ONCE WE HAD ADEQUATE EXPOSURE OF THE BROKEN HEAD NECK WAS REMOVED. THE ACETABULAR COMPONENT WAS INSPECTED AND FOUND TO BE IN GOOD CONDITION. A SQUARE TIP IMPACTOR WAS USED TO CHECK THAT THE ACETABULAR COMPONENT WAS WELL INGROWN, AND IT WAS. WE THEN TURNED OUR ATTENTION TO TH
Patient problems: Pain
MAUDE report 20727576 ↗InjuryNov 19, 2024Break; Break
ALLEGEDLY, ALL COMPONENTS WERE REMOVED FROM THE FEMUR. THE CANAL WAS COPIOUSLY IRRIGATED. THE FINAL COMPONENTS WERE IMPACTED INTO PLACE. THE HIP WAS AGAIN RELOCATED AND NOTED TO HAVE EXCELLENT RANGE OF MOTION AND EXCELLENT STABILITY. 66-YEAR-OLD MALE WITH A HISTORY OF A RIGHT TOTAL HIP ARTHROPLASTY DONE IN 2009 AND PREVIOUSLY WELL-FUNCTIONING PRESENTED TO MY OFFICE EARLIER THIS WEEK WITH 2 WEEKS OF INABILITY TO BEAR WEIGHT AND EXCRUCIATING PAIN IN THE RIGHT HIP. X-RAYS REVEAL A CATASTROPHICALLY FAILED RIGHT TOTAL HIP ARTHROPLASTY WITH A FRACTURE THROUGH THE DUAL MODULAR NECK. X-RAYS REVEAL A CATASTROPHICALLY FAILED RIGHT TOTAL HIP ARTHROPLASTY WITH A FRACTURE THROUGH THE DUAL MODULAR NECK. PATIENT HAD INFLAMMATORY MARKERS AS WELL AS AN ASPIRATION THAT WAS NONCONCERNING FOR INFECTION. WE IMMEDIATELY ENCOUNTERED THE BROKEN NECK SEGMENT AS WELL AS METALLOSIS WITHIN THE JOINT CAPSULE. THIS WAS EXCISED AND DEBRIDED. ONCE WE HAD ADEQUATE EXPOSURE OF THE BROKEN HEAD NECK WAS REMOVED. THE ACETABULAR COMPONENT WAS INSPECTED AND FOUND TO BE IN GOOD CONDITION. A SQUARE TIP IMPACTOR WAS USED TO CHECK THAT THE ACETABULAR COMPONENT WAS WELL INGROWN, AND IT WAS. WE THEN TURNED OUR ATTENTION TO TH
Patient problems: Pain
MAUDE report 20726229 ↗InjuryJun 21, 2024Break; Break
ALLEGEDLY, THE PATIENT FRACTURED OF THE PROFEMUR MODULAR NECK, BREAKING INTO TWO PIECES. AT THE TIME OF THE FRACTURE THE PATIENT HE FELL AND WAS IN SEVERE PAIN. PRODUCTS NOT REVISED: PRODUCT: LINEAGE® ACETABULAR SHELL 48MM SOLID HEMI FLARE STD GROUP 1 PRODUCT ID: 36450048; LOT#: 09228141; QTY:1. PRODUCT: LINEAGE® CERAMIC LINER 28MM X 46-50MM GROUP 1 PRODUCT ID: 71002846; LOT#: 11358775; QTY:1.
Patient problems: Pain
MAUDE report 19587774 ↗MalfunctionOct 23, 2023Break; Break
ALLEGEDLY, TI NECK FX CLAIM (10+) RIGHT SIDE.
Patient problems: Insufficient Information
MAUDE report 17987299 ↗InjuryAug 28, 2023Break; Difficult to Remove; Break; Difficult to Remove
ALLEGEDLY, THE PATIENT WAS PREVIOUSLY SYMPTOM-FREE FROM THE SIDE OF THE LEFT HIP, BUT AFTER A WALK SUDDENLY SLUMPED AND WAS UNABLE TO PUT WEIGHT ON THE LEG. BROKEN MODULAR NECK.
Patient problems: Insufficient Information
MAUDE report 17630829 ↗InjuryFeb 13, 2023Corroded; Corroded
ALLEGEDLY, PATIENT WAS REVISED DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS REVISION NJR NUMBER: (B)(6). SIDE:L. PRIMARY ASA: P1 - FIT AND HEALTHY. NON-MPO PRODUCTS: PRODUCT ID: 924760000 DURALOC SHELL 100 POLISHED HYDROXYAPATITE COATED 60MM/ LOT. NUMBER: 2732052/ QTY: 1. PRODUCT ID: 124260025 ENDURON PE LINER 10D 32/60 OR 72MM/ LOT. NUMBER: 1878654/ QTY: 1.
Patient problems: Metal Related Pathology
MAUDE report 16362089 ↗InjuryJul 26, 2022Corroded; Corroded
ALLEGEDLY, PATIENT EXPERIENCED PAIN IN HIS HIP AND TESTING REVEALED HIGH COBALT LEVELS THAT COULD LEAD TO COBALT POISONING. ADDITIONAL INFORMATION RECEIVED ON 07/11/2022: PATIENT UNDERWENT INDEX SURGERY ON HIS RIGHT HIP ON (B)(6) 2006. PATIENT SUBSEQUENTLY UNDERWENT REVISION SURGERY ON (B)(6) 2019. HE ALLEGES COCR CORROSION AT THE NECK/STEM JUNCTION, BUT HE DID NOT RECEIVE A COCR NECK OR STEM. HE DOES ALLEGE ELEVATED METAL IONS, AND HE DID RECEIVE MOM HEAD/CUP DEVICES.
Patient problems: Pain
MAUDE report 15105392 ↗InjuryMay 12, 2022Break; Break
ALLEGEDLY, HIP SUDDENLY STRUCTURALLY FAILED, BREAKING INTO TWO PIECES AT THE OBLONG TAPER OR DISTAL END OF THE DEVICE, WHERE IT SEATED IN THE POCKET OF THE PROFEMUR STEM CREATING PAIN.
Patient problems: Pain
MAUDE report 14376094 ↗InjuryApr 20, 2022Break; Break
InjuryMar 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ALLEGEDLY, MODULAR NECK CHANGE RESP. HIP STEM CHANGE. REASONS TO CHANGE THE NECK/STEM ARE NOT KNOWN. IT COULD BE EITHER A CHANGE OF NECK OR A COMPLETE CHANGE OF THE STEM. ALSO, IT IS NOT INDICATED THAT THE CUP HAS BEEN REVISED FROM PATIENT.
Patient problems: Insufficient Information
MAUDE report 13967761 ↗InjurySep 17, 2021Break; Break
ALLEGEDLY, THERE WAS A FRACTURE OF INTERCHANGEABLE NECK. INJURY WILL REQUIRE A REVISION SURGERY. JAZMP REFERENCE: (B)(4). ADDITIONAL INFORMATION RECEIVED ON 08/26/2021 FROM DISTRIBUTOR MARK MEDICAL: IMPLANTATION FACILITY NAME, DATE OF IMPLANTATION, DATE OF REVISION, PRODUCT ID ALSO REVISED (PROFEMUR STEM).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12489002 ↗InjuryApr 14, 2021Break; Break
ALLEGEDLY, THE MODULAR NECK FAILED BREAKING INTO TWO PIECES.
Patient problems: Failure of Implant
MAUDE report 11668907 ↗InjuryFeb 16, 2021Break
ALLEGEDLY, THE MODULAR NECK HAS FRACTURED. ADDITIONAL INFORMATION RECEIVED ON 01/29/2021: ADDING EXACT INCIDENT DATE AND INCIDENT DESCRIPTION. ALLEGEDLY, WHEN GOING FOR A WALK ON (B)(6) 2020, THE PATIENT FELT A "CRACKING" IN THE AREA OF THE LEFT HIP, WHEREUPON HE COULD NO LONGER STRAIN THE LEFT LOWER EXTREMITY. BASG REF. NO (B)(4).
Patient problems: Discomfort
MAUDE report 11335211 ↗InjuryDec 18, 2020Break; Break
ALLEGEDLY, THE PATIENT WAS WALKING ON THE STREET AND OF THE SUDDEN HE FELT DOWN. THE X-RAY SHOWN THAT THE NECK OF THE PROSTHESIS WAS BROKEN. THE REASON FOR REVISION WAS DUE TO FATIGUE FRACTURE OF THE IMPLANTED MODULAR NECK. ADDITIONAL INFORMATION RECEIVED ON 11/23/2020: SALES ORDER HISTORY (B)(6) 2009, PRODUCT ID AND LOT NUMBERS OBTAINED.
Patient problems: Bone Fracture(s); Fall
MAUDE report 11036357 ↗InjuryNov 27, 2020Break; Break
ALLEGEDLY, PATIENT WAS REVISED DUE TO IMPLANT FRACTURE STEM REVISION NJR NUMBER: (B)(4), SIDE: L, PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. ADDITIONAL INFORMATION PROVIDED BY WILL MALATESTA ON 11/23/2020: LOT INFORMATION. MHRA REFERENCE NO: (B)(4).
Patient problems: No Information
MAUDE report 10913368 ↗InjuryNov 4, 2020Break; Break
ALLEGEDLY, PROFEMUR MODULAR NECK FAILED BREAKING AT THE OBLONG TAPER OR DISTAL END OF THE DEVICE IN THE POCKET OF THE PROFEMUR STEM. (LEFT HIP).
Patient problems: No Information
MAUDE report 10784415 ↗InjuryOct 13, 2020Break; Break
ALLEGEDLY, PATIENT WAS REVISED DUE TO PROFEMUR MODULAR NECK FRACTURED. ADDITIONAL INFORMATION RECEIVED ON 09/10/2020 FROM (B)(6): ADDING PRODUCT INFORMATION. ADDITIONAL INFORMATION RECEIVED ON 09/24/2020 FROM (B)(6): UPDATING PRODUCT INFORMATION.
Patient problems: No Information
MAUDE report 10671330 ↗InjurySep 8, 2020Break; Difficult to Remove; Break; Difficult to Remove
ALLEGEDLY, THE PATIENT'S ACETABULAR COMPONENTS WERE REVISED ON (B)(6) 2008 DUE TO ROTATIONAL INSTABILITY, AND A HEMATOMA WAS FOUND AND REMOVED DURING THE OPERATION (INCIDENT GROUP #(B)(4)). ON (B)(6) 2017, THE PATIENT EXPERIENCED A MODULAR NECK FRACTURE. ALL COMPONENTS WERE REMOVED DURING THIS REVISION ON (B)(6) 2017.
Patient problems: No Information
MAUDE report 10502720 ↗InjuryJul 29, 2020Break; Break
ALLEGEDLY, PATIENT WAS REVISED DUE TO MODULAR NECK FRACTURE. REVISION NJR NUMBER: (B)(4) SIDE:R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. COMPONENT NOT REVISED: RIM-LOCK BIOLOX DELTA CERAMIC LINER 36MM ID GROUP E, PRODUCT ID PHA04510, LOT ID 1245. PROCOTYL L BEADED AND HA COATED CUP SIZE 52MM, PRODUCT ID PHA06262, LOT ID 1245.
Patient problems: No Information
MAUDE report 10337725 ↗InjuryMay 11, 2020Break; Break
ALLEGEDLY, THE FEMORAL NECK OF THE DEVICE SUDDENLY FAILED, BREAKING INTO PIECES. ADDITIONAL INFORMATION: LEFT HIP.
Patient problems: No Code Available
MAUDE report 10043265 ↗InjuryMar 25, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
ALLEGEDLY, PATIENT WAS REVISED DUE TO PROSTHESIS DISLOCATION COMPONENTS NOT REVISED: COTYLE "ALBI+" AVEC TROUS 50 - EPAISSEUR=3 - PPA45036, LOT R1199090. TIGE "JVC" A/COLLERETTE- A/CIMENT TAILLE 2 (POLIE PPV93004, LOT S0199104. NOYAU MUR 12DEG."ALBI+"50*28 POUR COTYLE EPAISSEUR 3 PPA41050, LOT S02101551.
Patient problems: No Information
MAUDE report 9881152 ↗InjuryMar 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT WAS REVISED DUE TO UNKNOWN.
Patient problems: No Information
MAUDE report 9841384 ↗InjuryMar 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT WAS REVISED DUE TO SEPTIC LOOSENING LINER IS FROM ANOTHER MANUFACTURER.
Patient problems: Unspecified Infection
MAUDE report 9819239 ↗InjuryMar 2, 2020Break; Break
ALLEGEDLY, PATIENT WAS REVISED DUE TO A BROKEN NECK.
Patient problems: No Code Available
MAUDE report 9776936 ↗InjuryFeb 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT WAS REVISED DUE TO UNKNOWN COMPONENTS NOT REVISED: COTYLE "ANCA FIT?" SANS TROUS A/REVET. HAP 56 PPR67356, LOT T02119378. INSERT CERAM "ANCA FIT?" 28/44 56-58/28 AL2.O3 BIOLOX FORTE PPR67512, LOT S11117461.
Patient problems: No Code Available
MAUDE report 9726774 ↗
Other Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented devices
- BIOLOX DELTA 1365-36-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented839 reports
- BIOLOX DELTA 1365-36-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented643 reports
- PINNACLE POROCOAT 1217-22-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented335 reports
- PINNACLE POROCOAT 1217-22-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented263 reports
- BIOLOX DELTA 1365-36-330Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented255 reports
- PINNACLE POROCOAT 1217-22-050Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented253 reports
- PINNACLE POROCOAT 1217-22-056Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented220 reports
- SUMMIT POROCOAT 1570-11-120Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented1 death204 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.