NA MCP-30Recalls & reported problems
Stryker GmbH · Silicone II MCP Implant Size 30 · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00886385022130), received between Jan 7, 2020 and Mar 14, 2025 — classified as 16 injuries.
The most frequently reported specific device problem is “Naturally Worn” (4 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem7
- Naturally Worn4
- Material Invagination2
- Break1
- Device Dislodged or Dislocated1
- Fracture1
- Unstable1
Patient problems
- Failure of Implant11
- Bone Fracture(s)1
- Deformity/ Disfigurement1
- Foreign Body In Patient1
- Implant Pain1
- Injury1
- Insufficient Information1
- Joint Laxity1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO MCP-30 PREFLEX IMPLANT BROKE & SURGEON PREFORMED A REVISION.
Patient problems: Failure of Implant; Foreign Body In Patient
MAUDE report 21612866 ↗InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 2, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO WORN OUT OVER TIME AND BROKEN.
Patient problems: Failure of Implant
MAUDE report 19767978 ↗InjuryApr 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - IMPLANT FAILED/REQUIRED INTERVENTION TO PREVENT IMPAIRMENT/DAMAGE.
Patient problems: Failure of Implant
MAUDE report 19102531 ↗InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 3, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE SIZE 30 IMPLANT DISLOCATED AND WAS REVISED TO A SIZE 20.
Patient problems: Insufficient Information
MAUDE report 14585369 ↗InjuryDec 7, 2021Break; Break
THE CUSTOMER REPORTED A BROKEN IMPLANT, THE PATIENT REQUIRED A REVISION SURGERY.
Patient problems: Failure of Implant
MAUDE report 12950049 ↗InjuryNov 11, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THE IMPLANTS WERE WORN, REQUIRING REVISION SURGERY.
Patient problems: Failure of Implant
MAUDE report 12793153 ↗InjuryNov 8, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THE IMPLANTS WERE WORN, REQUIRING REVISION SURGERY.
Patient problems: Failure of Implant
MAUDE report 12775917 ↗InjuryJul 29, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THE SILICONE IMPLANTS WERE WORN AND REQUIRED REPLACEMENT.
Patient problems: Failure of Implant
MAUDE report 12246842 ↗InjuryJul 29, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THE SILICONE IMPLANTS WERE WORN AND REQUIRED REPLACEMENT.
Patient problems: Failure of Implant
MAUDE report 12246835 ↗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 11735105 ↗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 11735104 ↗InjuryJan 7, 2020Fracture; Fracture
IT WAS REPORTED: REVISION OF A SILICONE MCP IMPLANT PLACED IN (B)(6) 2019. THE IMPLANT BROKE AT THE JUNCTION WITH THE DISTAL PHALANX. FOR THE PATIENT A RE-OPERATION 4 MONTHS AFTER THE PRIMARY SURGERY. PATIENT EXPERIENCED PAIN AND DEFORMITY.
Patient problems: Deformity/ Disfigurement; Failure of Implant; Injury; Pain
MAUDE report 9558366 ↗
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 5 OSTF-5Osteotec Limited · Prosthesis, Finger, Constrained, Polymer1 recall0 reports
- Osteotec Silicone Finger Implant - Size 3 OSTF-3Osteotec 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-50Stryker GmbH · PROSTHESIS, FINGER, CONSTRAINED, POLYMER14 reports
- NA MCPX-20Stryker GmbH · PROSTHESIS, FINGER, CONSTRAINED, POLYMER13 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 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