NA MCPX-40Recalls & reported problems
Stryker GmbH · MCP PreFlex Implant Size 40 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00886385025377), received between May 20, 2019 and May 23, 2024 — classified as 13 injuries.
The most frequently reported specific device problem is “Break” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem11
- Break2
- Fracture1
Patient problems
- Insufficient Information4
- Failure of Implant3
- No Known Impact Or Consequence To Patient2
- Unspecified Infection2
- Deformity/ Disfigurement1
- Implant Pain1
- Injury1
- Joint Laxity1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO MCP IMPLANT BROKE.
Patient problems: Failure of Implant
MAUDE report 19388699 ↗InjuryAug 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENTS KNUCKLES WERE SWOLLEN, REQUIRED INTERVENTION TO PREVENT IMPAIRMENT/DAMAGE.
Patient problems: Insufficient Information
MAUDE report 16402766 ↗InjuryFeb 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO SILICONE MCP IMPLANTS HAD FAILED OVER TIME. THE OLD IMPLANTS WERE REMOVED AND REPLACED WITH NEW IMPLANTS.
Patient problems: Failure of Implant
MAUDE report 16315511 ↗InjuryJan 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A REVISION TOOK PLACE DUE TO RECURRENCE OF DEFORMITY.
Patient problems: Deformity/ Disfigurement
MAUDE report 15360735 ↗InjuryAug 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT'S FINGER WAS INFECTED, REQUIRING REVISION SURGERY.
Patient problems: Unspecified Infection
MAUDE report 12377598 ↗InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER BECAME AWARE OF A POST MARKET CLINICAL FOLLOW-UP REPORT RECEIVED FROM URGENCE MAIN MULHOUSE, CLINIQUE DU DIACONAT, IN FRANCE. THE TITLE OF THIS REPORT IS ¿A RETROSPECTIVE DATA COLLECTION OF THE TREATMENT OF DEGENERATIVE OR POST-TRAUMATIC DISABILITIES IN THE METACARPOPHALANGEAL (MCP) AND PROXIMAL INTERPHALANGEAL (PIP) JOINTS WITH THE SILICONE AND PREFLEX PROSTHESES¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿SILICONE PIP AND PREFLEX MCP¿ PROSTHESIS. THIS STUDY INCLUDES RESEARCH DONE ON 109 PATIENTS (142 IMPLANTS) REQUIRING SURGERY BETWEEN THE PERIOD 2007 AND 2019. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE DETAILS FROM THE REPORT, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, NEW COMPLAINT WAS INITIATED IN THE SYSTEM FOR THE POST-OPERATIVE COMPLICATION MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES ULNAR OFF-AXIS.
Patient problems: Insufficient Information
MAUDE report 10780156 ↗InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER BECAME AWARE OF A POST MARKET CLINICAL FOLLOW-UP REPORT RECEIVED FROM URGENCE MAIN MULHOUSE, CLINIQUE DU DIACONAT, IN FRANCE. THE TITLE OF THIS REPORT IS ¿A RETROSPECTIVE DATA COLLECTION OF THE TREATMENT OF DEGENERATIVE OR POST-TRAUMATIC DISABILITIES IN THE METACARPOPHALANGEAL (MCP) AND PROXIMAL INTERPHALANGEAL (PIP) JOINTS WITH THE SILICONE AND PREFLEX PROSTHESES¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿SILICONE PIP AND PREFLEX MCP¿ PROSTHESIS. THIS STUDY INCLUDES RESEARCH DONE ON 109 PATIENTS (142 IMPLANTS) REQUIRING SURGERY BETWEEN THE PERIOD 2007 AND 2019. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE DETAILS FROM THE REPORT, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, NEW COMPLAINT WAS INITIATED IN THE SYSTEM FOR THE POST-OPERATIVE COMPLICATION MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES SMALL ULNAR OFF-AXIS.
Patient problems: Insufficient Information
MAUDE report 10779961 ↗InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER BECAME AWARE OF A POST MARKET CLINICAL FOLLOW-UP REPORT RECEIVED FROM URGENCE MAIN MULHOUSE, CLINIQUE DU DIACONAT, IN FRANCE. THE TITLE OF THIS REPORT IS ¿A RETROSPECTIVE DATA COLLECTION OF THE TREATMENT OF DEGENERATIVE OR POST-TRAUMATIC DISABILITIES IN THE METACARPOPHALANGEAL (MCP) AND PROXIMAL INTERPHALANGEAL (PIP) JOINTS WITH THE SILICONE AND PREFLEX PROSTHESES¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿SILICONE PIP AND PREFLEX MCP¿ PROSTHESIS. THIS STUDY INCLUDES RESEARCH DONE ON 109 PATIENTS (142 IMPLANTS) REQUIRING SURGERY BETWEEN THE PERIOD 2007 AND 2019. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE DETAILS FROM THE REPORT, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, NEW COMPLAINT WAS INITIATED IN THE SYSTEM FOR THE POST-OPERATIVE COMPLICATION MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES SMALL ULNAR OFF-AXIS.
Patient problems: Insufficient Information
MAUDE report 10779865 ↗InjuryOct 21, 2019Break; Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT WAS BROKEN INTO TWO PIECES. THIS WAS NOTED FOLLOWING REMOVAL FROM A PATIENT'S FINGER.
Patient problems: Failure of Implant; Injury; No Known Impact Or Consequence To Patient
MAUDE report 9213369 ↗InjuryMay 20, 2019Break
IT WAS REPORTED THAT THE PATIENT CAME IN FOR A REVISION OF THEIR MCP REPLACEMENT THAT WAS DONE A FEW MONTHS BACK. UPON EXPLANT, IT WAS IDENTIFIED THAT THE IMPLANT WAS BROKEN. IT WAS FURTHER REPORTED THAT THE IMPLANT WAS REPLACED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8625515 ↗
Other PROSTHESIS, FINGER, CONSTRAINED, POLYMER devices
- Osteotec Silicone Finger Implant - Size 4 OSTF-4Osteotec Limited · Prosthesis, Finger, Constrained, Polymer1 recall1 report
- Osteotec Silicone Finger Implant - Size 3 OSTF-3Osteotec Limited · Prosthesis, Finger, Constrained, Polymer1 recall0 reports
- Osteotec Silicone Finger Implant - Size 5 OSTF-5Osteotec Limited · Prosthesis, Finger, Constrained, Polymer1 recall0 reports
- NA PIP-30Stryker GmbH · PROSTHESIS, FINGER, CONSTRAINED, POLYMER27 reports
- NA PIP-20Stryker GmbH · PROSTHESIS, FINGER, CONSTRAINED, POLYMER21 reports
- NA PIP-10Stryker GmbH · PROSTHESIS, FINGER, CONSTRAINED, POLYMER16 reports
- NA MCP-30Stryker GmbH · PROSTHESIS, FINGER, CONSTRAINED, POLYMER16 reports
- NA MCP-50Stryker GmbH · PROSTHESIS, FINGER, CONSTRAINED, POLYMER14 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page