PROFEMURRecalls & reported problems across all models
Microport Orthopedics Inc. · 116 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 530
- Deaths reported
- 0
- Injuries reported
- 521
- Recalls
- 0
We found 116 models of PROFEMUR by Microport Orthopedics Inc. in the FDA's device registry (GUDID). Together they are named in 530 adverse event reports in the FDA's MAUDE database, received between Nov 5, 2015 and Sep 28, 2026 — classified as 521 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Break” (129 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported PROFEMUR problems
Device problems
- Break129
- Corroded126
- Insufficient Device Problem Information119
- Device Dislodged or Dislocated80
- Loss of Osseointegration28
- Material Disintegration19
- Appropriate Device Problem Term/Code Not Available17
- Material Frayed11
Patient problems
- Pain147
- No Information119
- Insufficient Information106
- Metal Related Pathology83
- Unspecified Infection37
- Loss of Range of Motion31
- Bone Fracture(s)24
- Failure of Implant16
PROFEMUR models
116 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- PROFEMUR® PHAC1254Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented63 reports
- PROFEMUR® PHAC1252Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous37 reports
- Profemur PHA01204Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented32 reports
- Profemur PHA01202Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented31 reports
- Profemur PHA01252Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented24 reports
- PROFEMUR® PHAC1204Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented24 reports
- Profemur PHA01254Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented23 reports
- PROFEMUR® PHAC1202Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous16 reports
- PROFEMUR® PHAC1232Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented14 reports
- Profemur PHA01232Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented11 reports
- Profemur PHA01244Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented10 reports
- PROFEMUR® PHAC1234Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented10 reports
- PROFEMUR® PRTL0024Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented9 reports
- Profemur PHA01234Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented8 reports
- PROFEMUR® PHAC1224Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented8 reports
- PROFEMUR® PHAC1242Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented8 reports
- PROFEMUR® PRTL0026Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented7 reports
- Profemur PHA01222Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented6 reports
- Profemur PHA01224Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented6 reports
- PROFEMUR® PHAC1214Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented6 reports
- PROFEMUR® PHAC1222Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous6 reports
- PROFEMUR® PHAC1244Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented6 reports
- PROFEMUR® PPW38354Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish6 reports
- PROFEMUR® PRTL0025Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented6 reports
- Profemur PHA00236Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented5 reports
- Profemur PHA00238Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented5 reports
- Profemur PHA00264Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented5 reports
- Profemur PHA01212Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented5 reports
- PROFEMUR® PPW39102Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented5 reports
- PROFEMUR® PHA00606Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented4 reports
- PROFEMUR® PHAC1212Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous4 reports
- PROFEMUR® PRGLCM04Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented4 reports
- Profemur PHA00234Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented3 reports
- Profemur PHA00240Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented3 reports
- Profemur PHA01242Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented3 reports
- Profemur PLS0R413Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented3 reports
- Profemur PLS0S413Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented3 reports
- PROFEMUR PPRCLS02Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented3 reports
- PROFEMUR® PRTLS027Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented3 reports
- Profemur PHAC1234Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous2 reports
- Profemur PHA00262Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- Profemur PHA00268Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- PROFEMUR® PHA00612Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- Profemur PHA03146Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented2 reports
- PROFEMUR® PHA0CLS5Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 reports
- PROFEMUR® PHAPCLS7Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- Profemur PLS0R411Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented2 reports
- Profemur PLS0S416Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented2 reports
- PROFEMUR PPRCLS09Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- Profemur PPW38020Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented2 reports
- Profemur PPW38024Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented2 reports
- PROFEMUR® PRGLDC04Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2 reports
- PROFEMUR® PRPR0006Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- PROFEMUR® PRTL0021Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented2 reports
- PROFEMUR® PRTL0023Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented2 reports
- PROFEMUR® PRTL0028Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- PROFEMUR® PYRD0004Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2 reports
- Profemur PHAC1202Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Profemur PHAC1204PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Profemur PHAC1222Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Profemur PHAC1224Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous1 report
- PROFEMUR® APA09028IMPACTOR1 report
- Profemur PHA00242Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
- Profemur PHA00244Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
- Profemur PHA00266Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- Profemur PHA01214Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented1 report
- Profemur PHA06002Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented1 report
- PROFEMUR® PHA0CLE5Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- PROFEMUR® PHA0CLS3Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 report
- PROFEMUR® PHA0E244Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
- PROFEMUR® PHA0S238Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
- PROFEMUR® PHA0S246Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
- PROFEMUR® PHAPCLE3Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 report
- PROFEMUR® PHAPE238Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
- PROFEMUR® PLLER010Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous1 report
- PROFEMUR® PLLER011Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
- PROFEMUR® PLLER014Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous1 report
- PROFEMUR® PLLES012Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
- Profemur PLS0R412Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented1 report
- Profemur PLS0R414Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented1 report
- Profemur PLS0R415Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented1 report
- PROFEMUR® PLSER012Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 report
- PROFEMUR® PLSSS011Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 report
- PROFEMUR PPRCLS01Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- PROFEMUR PPRCLS04Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- PROFEMUR PPRCLS08Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- PROFEMUR PPRCLS10Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Profemur PPW38000Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented1 report
- Profemur PPW38002Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented1 report
- Profemur PPW38004Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented1 report
- Profemur PPW38005Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented1 report
- Profemur PPW38022Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented1 report
- Profemur PPW38023Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented1 report
- Profemur PPW38025Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented1 report
- Profemur PPW38042Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented1 report
- Profemur PPW38044Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented1 report
- PROFEMUR® PPW39104Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented1 report
- PROFEMUR® PPW39110Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented1 report
- PROFEMUR® PRGL0003Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 report
- PROFEMUR® PRGL0004Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
Recent PROFEMUR adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Insufficient Device Problem Information
Patient problems: Pain
MAUDE report 50923576 ↗InjurySep 9, 2026Corroded; Device Dislodged or Dislocated
Allegedly, the patient underwent a right total hip arthroplasty with a Wright Medical Profemur® hip system. After years of satisfactory function, the patient began experiencing vibration, squeaking, and instability of the right hip while walking. Clinical evaluation revealed a broken and dislodged acetabular polyethylene liner, elevated cobalt and chromium levels, and corrosion at the modular neck-stem taper junction. During revision surgery, the surgeon confirmed gross corrosion of the Profemur® Plus CoCr modular neck, black metal-stained synovial fluid, metallosis, adverse local tissue reaction, and failure of the acetabular polyethylene liner. The corrosion reportedly generated metal debris and metal ion release, resulting in surrounding tissue damage and necessitating revision of the femoral prosthesis and acetabular components. Products implanted from other company: Stem and head. MPO product implanted during revision surgery: MicoPort A-Class 36mm Poly liner.
Patient problems: Metal Related Pathology
MAUDE report 50696368 ↗InjuryJul 29, 2026Insufficient Device Problem Information
Allegedly, patient was revised due to Infection.SRNJR Number: (b)(4).Side: L.Gender: F.Non-MPO products related:Product ID: 321.03.052 TRINITY NO HOLE SHELL 052MM TAPER SIZE 3.Product ID: 321.03.052 TRINITY ECIMA LINER SIZE 3 36MM NEUTRAL 4MM EPW.
Patient problems: Unspecified Infection
MAUDE report 50064297 ↗InjuryJul 28, 2026Break
Allegedly, patient was revised due to Implant Fracture of a nonceramic component - Stem. SRNJR Number: (b)(6).Side: L.Gender: M. Non revised MPO products:Product ID: PHA06264 PROCOTYL L ACETABULAR CUP BEADED COATED + HA 54 GROUP E/ Lot No.: 1530805/ QTY: 1.Product ID: PHA04510 RIMLOCK BIOLOX DELTA CERAMIC LINER 36 GROUP E/ Lot No.: 1476911/ QTY: 1.
Patient problems: Insufficient Information
MAUDE report 50048377 ↗InjuryJul 27, 2026Device Dislodged or Dislocated
Allegedly, patient was revised due to Dislocation/Subluxation/Adverse Soft Tissue Reaction to Particulate Debris. SRNJR Number: 6234077,Side: L ,Gender: F. Non revised MPO products:Product ID: PHA04510 RIMLOCK BIOLOX DELTA CERAMIC LINER 36 GROUP E/, Lot No.: 1516855, QTY: 1/Product ID: PHA06262 PROCOTYL L BEADED AND HA COATED CUP SIZE 52MM/ Lot No.: 1541120/ QTY: 1
Patient problems: Metal Related Pathology
MAUDE report 50027776 ↗InjuryJul 27, 2026Insufficient Device Problem Information
Allegedly, patient was revised due to Adverse Soft Tissue Reaction to Particulate Debris/Leg Length Discrepancy.SRNJR Number: (b)(6).Side: L.Gender: F.
Patient problems: Metal Related Pathology; Unequal Limb Length
MAUDE report 50027768 ↗InjuryApr 10, 2026Break; Noise, Audible
ALLEGEDLY, ON (B)(6) 2024, THE PATIENT WAS STANDING IN HIS LIVING ROOM AND BENT OVER TO PICK UP A PHONE CHARGER WHEN HE FELT A SUDDEN POP IN HIS RIGHT HIP AND IMMEDIATELY FELL TO THE FLOOR. HE EXPERIENCED PAIN AND WAS UNABLE TO BEAR WEIGHT ON HIS RIGHT LEG. X-RAYS REVEALED AN ANGULATED FRACTURE OF THE FEMORAL COMPONENT OF HIS RIGHT HIP ARTHROPLASTY HARDWARE, LATER CONFIRMED AS A FRACTURED MODULAR NECK STEM, WHICH NECESSITATED REVISION SURGERY PERFORMED ON (B)(6) 2024. NON-REVISED PRODUCTS: PRODUCT ID: DSBFGG58 DYNASTY® BF SHELL 58MM GROUP G/ LOT NO.: 1512229/ QTY: (B)(4). PRODUCT ID: 18080304 CANCELLOUS SELF-TAPPING 6.5MM BONE SCREW 3.5CM LENGTH/ LOT NO.: 1462885/ QTY: (B)(4).
Patient problems: Pain
MAUDE report 24841247 ↗InjuryFeb 11, 2026Break
ALLEGEDLY, REVISION SURGERY SCHEDULED FOR (B)(6) 2026. REP RECEIVED X-RAY ON (B)(6) 2026 SHOWING A BROKEN NECK. OSTEOMETY REQUIRED. WHILE IN SURGERY REQUESTED LINERS, WE DIDN'T HAVE, SO EVERYTHING WAS REVISED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24317709 ↗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 ↗InjuryOct 17, 2025Unstable; Unstable
ALLEGEDLY, PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2017 AT (B)(6). SHE WAS IMPLANTED WITH THE PROFEMUR® TOTAL HIP SYSTEM, CONSISTING OF A PROFEMUR Z TITANIUM STEM AND A SHORT COBALT-CHROMIUM MODULAR NECK. OVER TIME, THE DEVICE BEGAN TO FAIL AT THE NECK STEM JUNCTION, LEADING TO CORROSION AND THE RELEASE OF METALLIC DEBRIS. THIS CAUSED THE PATIENT TO EXPERIENCE PROGRESSIVE HIP PAIN, PROSTHESIS INSTABILITY, FORMATION OF A PSEUDOTUMOR, AND METALLOSIS (ACCUMULATION OF METALLIC PARTICLES IN THE SURROUNDING TISSUE). ON (B)(6) 2025, THE PATIENT UNDERWENT A REVISION SURGERY AT (B)(6). DURING THIS PROCEDURE, BOTH THE STEM AND THE MODULAR NECK OF THE PROFEMUR® SYSTEM WERE EXPLANTED, DUE TO CORROSION AND RELATED TISSUE DAMAGE. PATHOLOGY CONFIRMED CHRONICALLY INFLAMED FIBROTIC TISSUE WITH ENTRAPPED BONE PARTICLES AND METALLIC DEBRIS, ALONG WITH VISIBLE BLACK CORROSION AT THE NECK STEM JUNCTION, ESTABLISHING THAT THE FAILURE WAS CAUSED BY CORROSION OF THE COBALT-CHROMIUM MODULAR NECK COUPLED WITH THE TITANIUM STEM. PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2017 AT (B)(6). SHE WAS IMPLANTED WITH THE PROFEMUR® TOTAL HIP SYSTEM, CONSISTING OF A PROFEMUR Z TITANIUM
Patient problems: Metal Related Pathology
MAUDE report 23325675 ↗InjurySep 2, 2025Corroded; Insufficient Device Problem Information; Corroded; Insufficient Device Problem Information
ALLEGEDLY, A PATIENT WITH BMI OVER 40 AND HAS ADVISED LEGAL THAT BROUGHT SURGEON TO FOLLOW UP WITH HOSPITAL. ADDITIONAL INFORMATION RECEIVED ON 09-19-2025: THE PATIENT WAS EXPERIENCING PAIN, POSSIBLY FROM METAL REACTION BETWEEN COCR MODULAR NECK AND FEMORAL STEM. IT WAS REPORTED THAT BONE AND TISSUE WAS REMOVED DURING THE REVISION WITH VISIBLE EVIDENCE OF A REACTION. THE COCR NECK WAS REPLACED WITH A TITANIUM MODULAR NECK. ADDITIONAL INFORMATION RECEIVED ON 01-27-2026: REVISION SURGERY WAS NECESSARY DUE TO CORROSION AT THE NECK-STEM JUNCTION OF THE DEVICE. MEDICAL RECORDS INDICATE, AMONG OTHER THINGS: DARK GREY TO BLACK RESIDUE ON THE FEMORAL NECK COMPONENT FROM THAT JUNCTION INTO THE FEMORAL STEM; METALLOSIS WITH SOFT TISSUE EROSION; AND TENDON REPAIRS RELATED TO TISSUE NECROSIS AND PSEUDOTUMOR FORMATION.
Patient problems: Insufficient Information; Metal Related Pathology; Pain
MAUDE report 22935258 ↗InjuryApr 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, THE DOCTOR REPORTS THAT THE PATIENT HAS EARLY POLYETHYLENE WEAR AND OSTEOLYSIS OF THE FEMUR.
Patient problems: Osteolysis
MAUDE report 21940104 ↗InjuryApr 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, ON (B)(6) 2024, THE PATIENT REPORTED COMPLICATIONS FROM THE REVISION DEVICES. SECOND REVISION SURGERY EXPECTED. NO OTHER INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 21769049 ↗InjuryMar 7, 2025Corroded; Corroded
ALLEGEDLY, DOCTOR RECOMMENDED THE REVISION SURGERY AFTER PLAINTIFF PRESENTED WITH PROGRESSIVE RIGHT HIP PAIN, ELEVATED ION LEVELS, METALLOSIS CHANGES AROUND THE FEMORAL NECK AND SURROUNDING SOFT TISSUES AROUND THE PROXIMAL FEMUR, ADVERSE LOCAL TISSUE REACTION AND LACK OF MOBILITY. THE REVISION WAS NECESSARY BECAUSE THE DEVICE FAILED DUE TO CORROSION AT THE NECK-STEM JUNCTION OF THE DEVICE. PRODUCTS NOT SPECIFIED THEY WERE REVISED: PRODUCT ID: DBFPGD52 DYNASTY® BF SHELL PRIMARY 52MM GROUP D, LOT: 1684715, QTY:1.
Patient problems: Loss of Range of Motion; Pain
MAUDE report 21548583 ↗InjuryMar 7, 2025Corroded; Corroded
ALLEGEDLY, DOCTOR RECOMMENDED THE REVISION SURGERY AFTER PLAINTIFF PRESENTED WITH PROGRESSIVE RIGHT HIP PAIN, ELEVATED ION LEVELS, METALLOSIS CHANGES AROUND THE FEMORAL NECK AND SURROUNDING SOFT TISSUES AROUND THE PROXIMAL FEMUR, ADVERSE LOCAL TISSUE REACTION AND LACK OF MOBILITY. THE REVISION WAS NECESSARY BECAUSE THE DEVICE FAILED DUE TO CORROSION AT THE NECK-STEM JUNCTION OF THE DEVICE. PRODUCTS NOT SPECIFIED THEY WERE REVISED: PRODUCT ID: DBFPGD52 DYNASTY® BF SHELL PRIMARY 52MM GROUP D, LOT: 1684715, QTY:1.
Patient problems: Loss of Range of Motion; Metal Related Pathology; Pain
MAUDE report 21547324 ↗
Other Microport Orthopedics Inc. products
All Microport Orthopedics Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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