CONSERVE® 38AM4435Recalls & reported problems
Microport Orthopedics Inc. · CONSERVE® A-CLASS® BFH® HEAD LONG NECK 44MM · Class 3 · Implant
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI M68438AM44351), received between Nov 19, 2019 and Dec 18, 2020 — classified as 7 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information3
- Material Disintegration3
- Corroded2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Reaction5
- Metal Related Pathology3
- No Information1
- Unspecified Infection1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryDec 18, 2020Adverse Event Without Identified Device or Use Problem
ALLEGEDLY, PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. HEAD WAS REMOVED AND REPLACED. COMPONENTS NOT REVISED: DYNASTY®COCR LINER 44MM GRP G PRODUCT NUMBER : DLCOGG44 LOT NUMBER: 0801181920. DYNASTY® BF SHELL 60MM GROUP G PRODUCT NUMBER : DSBFGG60 LOT NUMBER: 0501117006. PROFEMUR® NECK NEUTRAL SHORT COBALT CHROME PRODUCT NUMBER : PHAC1202 LOT NUMBER: 0801192249. PROFEMUR® RAZ STEM SZ 8 PRODUCT NUMBER : PYRD0008 LOT NUMBER: 077426987. CANCELLOUS SELF-TAPPING 6.5MM BONE SCREW 2.5CM LENGTH PRODUCT NUMBER : 18080302 LOT NUMBER: 0701167654. CANCELLOUS SELF-TAPPING 6.5MM BONE SCREW 4.0CM LENGTH PRODUCT NUMBER : 18080305 LOT NUMBER: 0301089651.
Patient problems: Unspecified Infection
MAUDE report 11037416 ↗InjuryDec 8, 2020Corroded; Corroded
ALLEGEDLY, REVISION SURGERY WAS NECESSARY BECAUSE THE DEVICE FAILED DUE TO ADVERSE TISSUE REACTION TO METAL DEBRIS, CORROSION AND RESULTANT METAL IONS. LEFT HIP.
Patient problems: Metal Related Pathology
MAUDE report 10971244 ↗InjuryAug 12, 2020Corroded; Material Disintegration; Corroded; Material Disintegration
ALLEGEDLY, PATIENT REVISED DUE TO METAL DEBRIS, CORROSION, PSEUDOTUMORS AND RESULTANT METAL IONS. ADDITIONAL INFORMATION: LEFT HIP. COMPONENTS WERE REMOVED , INCLUDING THE METAL LINER AND METAL FEMORAL HEAD , THE SHELL AND STEM WERE RETAINED. ADDITIONAL INFORMATION RECEIVED ON 07/20/2020 : ADDING PRODUCT NUMBERS AND LOT ID?S.
Patient problems: Reaction
MAUDE report 10396056 ↗InjuryApr 7, 2020Material Disintegration; Insufficient Device Problem Information; Material Disintegration; Insufficient Device Problem Information
ALLEGEDLY, INFORMATION RECEIVED FROM ATTENDING PHYSICIAN ON (B)(6) 2011 A TOTAL HIP ARTHROPLASTY WAS PERFORMED. ON (B)(6) 2019 DUE TO ADVERSE REACTION TO METAL DEBRIS (ARMD) SUSPECTED HIP ARTHROPLASTY AND A REVISION WAS PERFORMED ON (B)(6) 2019.
Patient problems: Metal Related Pathology; Reaction
MAUDE report 9933135 ↗InjuryFeb 26, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, THE PATIENT WAS REVISED DUE TO A SUSPECTED ADVERSE TISSUE REACTION TO THE IMPLANTED PRODUCTS. DURING REVISION, THE HEAD AND NECK WERE REMOVED BECAUSE OF DAMAGE THAT APPEARED TO BE IMPLANT WEAR. THE PHYSICIAN HAS REQUESTED THAT THE EXHIBITED WEAR AND DISCOLORATION OF THE REVISED PRODUCTS BE ANALYZED. THE ACETABULAR CUP AND FEMORAL STEM WILL NOT BE RETURNED. ADDITIONAL INFORMATION RECEIVED FROM (B)(6) ON 02/26/2021: HOSPITAL AND PHYSICIAN INFORMATION.
Patient problems: Metal Related Pathology; Reaction
MAUDE report 9758795 ↗InjuryJan 29, 2020Insufficient Device Problem Information; 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 9642311 ↗InjuryNov 19, 2019Material Disintegration; Material Disintegration
ALLEGEDLY, THE PATIENT WAS REVISED DUE TO ADVERSE TISSUE REACTION TO METAL DEBRIS , CORROSION AND RESULTANT METAL IONS, DUE TO THE METAL ON METAL DESIGN BETWEEN THE ARTICULATING SURFACES. NONE MPO COMPONENT CONFIRMED BY INVOICE ORDER (B)(4): NOVATION FEMORAL STEM, CATALOG NO. 160-00-13, SERIAL NO. (B)(4).
Patient problems: No Information; Reaction
MAUDE report 9344909 ↗
Other Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) devices
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- BIOLOX DELTA 1365-28-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)43 reports
- ASPHERE 1365-52-100Depuy (Ireland) · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)39 reports
- ASPHERE 1365-05-100Depuy (Ireland) · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)29 reports
- ASPHERE 1365-06-100Depuy (Ireland) · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)29 reports
- Taperloc Complete Micro Primary Femoral 51-107130Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)23 reports
- Taperloc Complete Micro Primary Femoral 51-107120Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)19 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.