NA MCP-50Recalls & reported problems
Stryker GmbH · Silicone II MCP Implant Size 50 · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00886385022178), received between Apr 26, 2021 and Jul 2, 2026 — classified as 14 injuries.
The most frequently reported specific device problem is “Fracture” (6 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 Problem6
- Fracture6
- Break3
- Device Dislodged or Dislocated1
- Patient Device Interaction Problem1
Patient problems
- Failure of Implant9
- Unspecified Infection3
- Implant Pain2
- Joint Laxity1
- No Clinical Signs, Symptoms or Conditions1
- Rheumatoid Arthritis1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjuryJul 2, 2026Patient Device Interaction Problem
REVISION SURGERY - DUE TO IMPLANT WAS IN THREE PIECES. JOINT UNSTABLE.
Patient problems: Failure of Implant; Joint Laxity
MAUDE report 25699918 ↗InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem
IMPLANTS WERE INTACT, PATIENT CAME IN WITH PAIN AND ANCHORS WERE NOT STRAIGHT.
Patient problems: Implant Pain
MAUDE report 24837583 ↗InjuryDec 8, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
InjuryMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 4, 2023Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE PATIENT BROKE HIS FINGER RESULTING IN A REVISION SURGERY.
Patient problems: Failure of Implant
MAUDE report 16098881 ↗InjuryDec 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "THE PATIENT PRESENTED WITH INFECTION, CAUSE UNKNOWN. REPLACED IMPLANT WITH IDENTICAL IMPLANT."
Patient problems: Unspecified Infection
MAUDE report 16048852 ↗InjuryNov 30, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT A MCP SILICONE IMPLANT MOVED OUT OF PLACE. HAD TO RE-IMPLANT NEW MCP-50. PATIENT HAS RA CAUSING PROXIMAL PLALANX TO SUBLUX/ROTATE, RESULTING IN IMPLANT MOVING OUT OF PLACE.
Patient problems: Failure of Implant; Rheumatoid Arthritis
MAUDE report 15885172 ↗InjuryOct 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PRIMARY SURGERY FOR MCP ARTHRITIS TOOK PLACE ON (B)(6) 2022. A COUPLE OF WEEKS LATER THE FINGER GOT INFECTED SO AN I&D AND MCP IMPLANT SWAP OUT WAS PERFORMED.
Patient problems: Unspecified Infection
MAUDE report 15690660 ↗InjuryJul 29, 2022Break; Fracture; Break; Fracture
AS REPORTED: "SURGEON ASKED FOR AN X-RAY BECAUSE PATIENT WAS FEELING TOO MUCH PAIN. REVISION DUE TO BROKEN IMPLANT."
Patient problems: Failure of Implant; Implant Pain
MAUDE report 15130985 ↗InjuryMar 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "AFTER THREE YEARS, THE SILICONE MCP JOINT REPLACEMENT NEEDED TO BE REPLACED. A REVISION SURGERY OCCURRED. NO COMPLICATIONS DURING SURGERY, ONE IMPLANT REMOVED AND REPLACED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13743326 ↗InjuryAug 4, 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 12277465 ↗InjuryJul 14, 2021Fracture; Fracture
IT WAS REPORTED THE INITIAL IMPLANT FAILED, BROKE APART; REVISION SURGERY WAS PERFORMED.
Patient problems: Failure of Implant
MAUDE report 12169744 ↗InjuryJul 14, 2021Fracture; Fracture
IT WAS REPORTED THE INITIAL IMPLANT FAILED, BROKE APART; REVISION SURGERY WAS PERFORMED.
Patient problems: Failure of Implant
MAUDE report 12169742 ↗InjuryApr 26, 2021Break; Break
IT WAS REPORTED THE SILICONE WAS BROKEN, RESULTING IN REVISION SURGERY.
Patient problems: Failure of Implant
MAUDE report 11728936 ↗
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 MCP-30Stryker GmbH · PROSTHESIS, FINGER, CONSTRAINED, POLYMER16 reports
- NA PIP-10Stryker GmbH · PROSTHESIS, FINGER, CONSTRAINED, POLYMER16 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.
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