NA MCP-40Recalls & reported problems
Stryker GmbH · Silicone II MCP Implant Size 40 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00886385022154), received between Apr 27, 2021 and Jan 30, 2025 — classified as 9 injuries.
The most frequently reported specific device problem is “Naturally Worn” (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. 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 Problem3
- Naturally Worn3
- Fracture2
- Break1
- Material Invagination1
- Unstable1
Patient problems
- Failure of Implant7
- Insufficient Information2
- Implant Pain1
- Joint Laxity1
- Unspecified Infection1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryJan 30, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INSTABILITY.
Patient problems: Joint Laxity; Unspecified Infection
MAUDE report 21278672 ↗InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PAIN.
Patient problems: Failure of Implant; Implant Pain
MAUDE report 19000756 ↗InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 18754790 ↗InjuryJun 3, 2022Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE SILICONE IMPLANT BROKE, LEADING TO A REVISION.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 14590999 ↗InjuryNov 8, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THE IMPLANTS WERE WORN, REQUIRING REVISION SURGERY.
Patient problems: Failure of Implant
MAUDE report 12775918 ↗InjuryAug 5, 2021Fracture; Fracture
IT WAS REPORTED BOTH SILICONE IMPLANTS HAD SNAPPED INTO TWO PIECES. BOTH SILICONE IMPLANTS IN THE RING AND PINKY FINGER WERE EXPLANTED AND NEW IMPLANTS WERE PUT IN.
Patient problems: Failure of Implant
MAUDE report 12280316 ↗InjuryJul 29, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THE SILICONE IMPLANTS WERE WORN AND REQUIRED REPLACEMENT.
Patient problems: Failure of Implant
MAUDE report 12246840 ↗InjuryJul 29, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THE SILICONE IMPLANTS WERE WORN AND REQUIRED REPLACEMENT.
Patient problems: Failure of Implant
MAUDE report 12246837 ↗InjuryApr 27, 2021Material Invagination; Material Invagination
AS REPORTED: "TAKEN OUT OLD IMPLANTS PUTTING IN NEW ONES. PATIENT HAD FUSED WRIST IMPLANTS, HAD COLLAPSED OVER TIME. HAD TO BE TAKEN OUT IN PIECES".
Patient problems: Failure of Implant
MAUDE report 11735107 ↗
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