CONSERVE® 38AM4635Recalls & reported problems
Microport Orthopedics Inc. · CONSERVE® A-CLASS® BFH® HEAD LONG NECK 46MM · Class 3 · Implant
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M68438AM46351), received between Oct 3, 2019 and Sep 15, 2020 — classified as 5 injuries.
The most frequently reported specific device problem is “Material Disintegration” (3 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
Device problems
- Material Disintegration3
- Insufficient Device Problem Information2
- Corroded1
- Device Dislodged or Dislocated1
Patient problems
- No Information3
- Reaction3
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2020Corroded; Material Disintegration; Corroded; Material Disintegration
ALLEGEDLY, PATIENT WAS REVISED DUE TO METALLOSIS OF HER LEFT HIP. THE REVISION PROCEDURE REFERENCES EVIDENCE OF CORROSION.
Patient problems: No Information
MAUDE report 10536880 ↗InjurySep 15, 2020Material Disintegration; Material Disintegration
ALLEGEDLY, PATIENT WAS REVISED DUE TO METALLOSIS OF HER RIGHT HIP.
Patient problems: No Information
MAUDE report 10535556 ↗InjuryJan 30, 2020Device Dislodged or Dislocated; Insufficient Device Problem Information; Device Dislodged or Dislocated; Insufficient Device Problem Information
ALLEGEDLY, CUP IS DISLOCATED, METAL ON METAL. 56 DEPUY CUP WENT IN WITH A 40MM T4 LINER OF THEIRS. MODULAR SHORT STRAIGHT NECK AND CERAMIC 40MM LONG HEAD WERE IMPLANTED.
Patient problems: Reaction
MAUDE report 9646424 ↗InjuryOct 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, THE PATIENT HAD PROBLEMS WITH HER LEFT HIP FOLLOWING HER 2010 SURGERY. PLAINTIFF UNDERWENT A SECOND LEFT HIP SURGERY ON (B)(6) 2017. COMPONENTS CAUSED METAL TO BREAK OFF OF THE SYSTEMS PARTS AND BECOME PERMANENT CONTAMINANTS WITHIN PATIENTS BODIES. THE DESIGN ALLOW MOM CONTACT WITHIN THE PROSTHETIC JOINT SYSTEM AND THEREBY CAUSE FLAKES OF METAL TO CONTAMINATE THE BLOODSTREAM OF THE PATIENT INCLUDING PLAINTIFF HEREIN AND CAUSE ASSOCIATED TISSUE DAMAGE.
Patient problems: Reaction
MAUDE report 9198030 ↗InjuryOct 3, 2019Material Disintegration; Material Disintegration
ALLEGEDLY, UNDERWENT SURGERY OF A TOTAL PROSTHETIC HIP DEVICE ON HER LEFT SIDE, BECAUSE OF INCREASINGLY WORSENING PROBLEMS WITH HER LEFT HIP, FOLLOWING HER 2010 SURGERY. PLAINTIFF UNDERWENT A SECOND LEFT HIP SURGERY. THE PARTS WAS UNREASONABLY DANGEROUS BECAUSE THE PROCESS IN THE BODY OF THE PATIENT WHEREBY METAL COMPONENTS RUBBERED ON OTHER METAL COMPONENT PARTS AND CAUSED METAL TO BREAK OFF OF THE SYSTEM PARTS AND BECOME PERMANENT CONTAMINANTS WITHIN THE PATIENTS BODIES, INCLUDING PLAINTIFF HEREIN AND CAUSING THE PATIENTS PERMANENT PHYSICAL AND SYSTEMATIC INJURY.
Patient problems: No Information; Reaction
MAUDE report 9150835 ↗
Other Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) devices
- Omnifit 2001-2246Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained (metal cemented acetabular component)1 recall0 reports
- Taperloc Complete Micro Primary Femoral 51-107150Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained (metal cemented acetabular component)41 reports
- Taperloc Complete Micro Primary Femoral 51-107140Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained (metal cemented acetabular component)36 reports
- Dynasty DSBFGD52Microport Orthopedics Inc. · Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)12 reports
- CONSERVE® 38AM4600Microport Orthopedics Inc. · Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)8 reports
- CONSERVE® 38AM4804Microport Orthopedics Inc. · Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)7 reports
- CONSERVE® 38AM4404Microport Orthopedics Inc. · Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)6 reports
- Dynasty DSBFGF56Microport Orthopedics Inc. · Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)5 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.