NA MCP-10Recalls & reported problems
Stryker GmbH · Silicone II MCP Implant Size 10 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00886385022093), received between May 26, 2021 and Apr 3, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Break” (1 report).
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 Problem2
- Break1
- Device Dislodged or Dislocated1
- Fracture1
Patient problems
- Failure of Implant3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO SILICONE MCP IMPLANTS PUT IN MANY YEARS AGO BROKE AND NEEDED TO BE REPLACED.
Patient problems: Failure of Implant
MAUDE report 21770074 ↗InjuryMay 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO IMPLANTS WERE BROKEN IN SITU.
Patient problems: Failure of Implant
MAUDE report 19348221 ↗InjurySep 30, 2022Break; Fracture; Break; Fracture
IT WAS REPORTED THAT A SILICONE IMPLANT WORE OUT AND BROKE IN TWO RESULTING IN A REVISION OF THE DEVICE.
Patient problems: Failure of Implant
MAUDE report 15515062 ↗InjuryMay 26, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THE DEVICE WAS LOOSE, REQUIRING REVISION SURGERY.
Patient problems: Insufficient Information
MAUDE report 11885444 ↗
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.
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