NA MCP-20Recalls & reported problems
Stryker GmbH · Silicone II MCP Implant Size 20 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00886385022116), received between Apr 27, 2021 and Feb 25, 2025 — classified as 8 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated3
- Adverse Event Without Identified Device or Use Problem2
- Break1
- Fracture1
- Inadequacy of Device Shape and/or Size1
- Material Invagination1
- Naturally Worn1
Patient problems
- Insufficient Information5
- Failure of Implant3
- Implant Pain1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryFeb 25, 2025Adverse 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 21465305 ↗InjuryFeb 25, 2025Adverse 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 21465302 ↗InjuryJul 12, 2022Break; Fracture; Break; Fracture
AS REPORTED: "PATIENT HAD INITIAL SURGERY (B)(6) 2019. STARTED TO EXPERIENCE SOME PAIN RECENTLY AND SURGEON DETERMINED THAT HER IMPLANT HAD FRACTURED AND BROUGHT HER IN FOR A REVISION. REVISION WAS DONE (B)(6) 2022 AND A MCP-X 20 WAS IMPLANTED".
Patient problems: Failure of Implant; Implant Pain
MAUDE report 14985165 ↗InjuryJun 6, 2022Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE INITIAL IMPLANTED DEVICE WAS TOO SMALL AND DISLOCATED. SURGEON IMPLANTED A LARGER IMPLANT.
Patient problems: Insufficient Information
MAUDE report 14604877 ↗InjuryNov 11, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THE IMPLANTS WERE WORN, REQUIRING REVISION SURGERY.
Patient problems: Failure of Implant
MAUDE report 12793170 ↗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 11885449 ↗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 11885443 ↗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 11735103 ↗
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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