NA PIP-20Recalls & reported problems
Stryker GmbH · Silicone PIP Implant Size 20 · Class 2 · Implant
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00886385021539), received between Oct 22, 2018 and Jun 3, 2026 — classified as 21 injuries.
The most frequently reported specific device problem is “Break” (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. 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 Problem15
- Break3
- Appropriate Device Problem Term/Code Not Available1
- Device Dislodged or Dislocated1
- Fracture1
- Naturally Worn1
- Unstable1
Patient problems
- Failure of Implant6
- Insufficient Information4
- Implant Pain3
- Loss of Range of Motion3
- Joint Dislocation2
- Joint Laxity2
- Pain2
- Erythema1
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
InjuryJun 3, 2026Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PAIN AND INSTABILITY.
Patient problems: Joint Laxity; Pain
MAUDE report 25369521 ↗InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT HAD DISCOMFORT SO DOCTOR WANTED TO SWITCH OUT SIZES.
Patient problems: Implant Pain
MAUDE report 23306688 ↗InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO BROKEN AND DECAYING SILICONE IMPLANT.
Patient problems: Failure of Implant
MAUDE report 22465235 ↗InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO SURGEON MAY HAVE PUT IN SILICONE KNUCKLE CROOKED. BUT PATIENT ALSO WAS IN CAR WRECK.
Patient problems: Insufficient Information
MAUDE report 18585151 ↗InjuryDec 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO STIFFNESS.
Patient problems: Loss of Range of Motion
MAUDE report 18415509 ↗InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A REVISION TOOK PLACE DUE TO PAIN AND A POSSIBLE INFECTION.
Patient problems: Implant Pain; Unspecified Infection
MAUDE report 15533984 ↗InjuryJun 3, 2022Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE IMPLANT BROKE WHICH RESULTED IN A REVISION.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 14591007 ↗InjuryMar 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PHYSICIAN THOUGHT THE PRODUCT WAS BROKEN BUT WHEN HE WENT IN TO REPLACE IT THERE WAS NOTHING BROKEN OR DAMAGED WITH THE IMPLANT. PATIENT REPORTED PAIN. THERE WAS NO ISSUE WITH IMPLANT HE UPSIZED THE ONE THAT WAS IN THE PATIENT.
Patient problems: Implant Pain
MAUDE report 13674512 ↗InjuryMar 4, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE "PATIENT DISLOCATED." THE PATIENT UNDERWENT A REVISION SURGERY.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 13674392 ↗InjuryDec 14, 2021Break; Break
AS REPORTED: "THE INITIAL IMPLANT WAS DONE 20+ YEARS AGO. FAILURE WAS DUE TO IMPLANT BREAKDOWN, BECAUSE IT WAS DONE SO LONG AGO. A REVISION SURGERY WAS PERFORMED."
Patient problems: Failure of Implant
MAUDE report 13005696 ↗InjurySep 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE DOCTOR DETERMINED HE DID NOT REMOVE ENOUGH OSTEOPHYTES DURING THE PROCEDURE. HE REPLACED THE DEVICE WITH A FRESH ONE.
Patient problems: Insufficient Information
MAUDE report 12454048 ↗InjuryAug 24, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THE PATIENT HAD REVISION SURGERY DUE TO WEAR AND TEAR ON THE IMPLANT. THE ORIGINAL SURGERY OCCURRED APPROXIMATELY 10 YEARS AGO.
Patient problems: Failure of Implant
MAUDE report 12358173 ↗InjuryMay 24, 2021Break; Break
IT WAS REPORTED THE SILICONE PIP IMPLANT WAS BROKEN, RESULTING IN REVISION SURGERY.
Patient problems: Failure of Implant
MAUDE report 11870332 ↗InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER BECAME AWARE OF A POST MARKET CLINICAL FOLLOW-UP REPORT RECEIVED FROM (B)(6), IN FRANCE. THE TITLE OF THIS REPORT IS ¿A RETROSPECTIVE DATA COLLECTION OF THE TREATMENT OF DEGENERATIVE OR POST-TRAUMATIC DISABILITIES IN THE METACARPOPHALANGEAL (MCP) AND PROXIMAL INTERPHALANGEAL (PIP) JOINTS WITH THE SILICONE AND PREFLEX PROSTHESES¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿SILICONE PIP AND PREFLEX MCP¿ PROSTHESIS. THIS STUDY INCLUDES RESEARCH DONE ON 109 PATIENTS (142 IMPLANTS) REQUIRING SURGERY BETWEEN THE PERIOD 2007 AND 2019. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE DETAILS FROM THE REPORT, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, NEW COMPLAINT WAS INITIATED IN THE SYSTEM FOR THE POST-OPERATIVE COMPLICATION MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES SMALL ULNAR OFF-AXIS.
Patient problems: Insufficient Information
MAUDE report 10779952 ↗InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER BECAME AWARE OF A POST MARKET CLINICAL FOLLOW-UP REPORT RECEIVED FROM (B)(6), IN FRANCE. THE TITLE OF THIS REPORT IS ¿A RETROSPECTIVE DATA COLLECTION OF THE TREATMENT OF DEGENERATIVE OR POST-TRAUMATIC DISABILITIES IN THE METACARPOPHALANGEAL (MCP) AND PROXIMAL INTERPHALANGEAL (PIP) JOINTS WITH THE SILICONE AND PREFLEX PROSTHESES¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿SILICONE PIP AND PREFLEX MCP¿ PROSTHESIS. THIS STUDY INCLUDES RESEARCH DONE ON 109 PATIENTS (142 IMPLANTS) REQUIRING SURGERY BETWEEN THE PERIOD 2007 AND 2019. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE DETAILS FROM THE REPORT, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, NEW COMPLAINT WAS INITIATED IN THE SYSTEM FOR THE POST-OPERATIVE COMPLICATION MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES DESAXATION (RADIOGRAPHIC CONTROL- ULNAR OFF-AXIS).
Patient problems: Malunion of Bone
MAUDE report 10778800 ↗InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER BECAME AWARE OF A POST MARKET CLINICAL FOLLOW-UP REPORT RECEIVED FROM URGENCE MAIN MULHOUSE, CLINIQUE DU DIACONAT, IN FRANCE. THE TITLE OF THIS REPORT IS ¿A RETROSPECTIVE DATA COLLECTION OF THE TREATMENT OF DEGENERATIVE OR POST-TRAUMATIC DISABILITIES IN THE METACARPOPHALANGEAL (MCP) AND PROXIMAL INTERPHALANGEAL (PIP) JOINTS WITH THE SILICONE AND PREFLEX PROSTHESES¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿SILICONE PIP AND PREFLEX MCP¿ PROSTHESIS. THIS STUDY INCLUDES RESEARCH DONE ON 109 PATIENTS (142 IMPLANTS) REQUIRING SURGERY BETWEEN THE PERIOD 2007 AND 2019. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE DETAILS FROM THE REPORT, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, NEW COMPLAINT WAS INITIATED IN THE SYSTEM FOR THE POST-OPERATIVE COMPLICATION MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES STIFFNESS (PIP AT D3) FOR WHICH TENOARTHROLYSIS WAS DONE LATER.
Patient problems: Loss of Range of Motion
MAUDE report 10778537 ↗InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER BECAME AWARE OF A POST MARKET CLINICAL FOLLOW-UP REPORT RECEIVED FROM URGENCE MAIN MULHOUSE, CLINIQUE DU DIACONAT, IN FRANCE. THE TITLE OF THIS REPORT IS ¿A RETROSPECTIVE DATA COLLECTION OF THE TREATMENT OF DEGENERATIVE OR POST-TRAUMATIC DISABILITIES IN THE METACARPOPHALANGEAL (MCP) AND PROXIMAL INTERPHALANGEAL (PIP) JOINTS WITH THE SILICONE AND PREFLEX PROSTHESES¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿SILICONE PIP AND PREFLEX MCP¿ PROSTHESIS. THIS STUDY INCLUDES RESEARCH DONE ON 109 PATIENTS (142 IMPLANTS) REQUIRING SURGERY BETWEEN THE PERIOD 2007 AND 2019. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE DETAILS FROM THE REPORT, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, NEW COMPLAINT WAS INITIATED IN THE SYSTEM FOR THE POST-OPERATIVE COMPLICATION MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES STIFFNESS (PIP AT D2) FOR WHICH TENOARTHROLYSIS WAS DONE LATER.
Patient problems: Loss of Range of Motion
MAUDE report 10778536 ↗InjuryOct 22, 2018Appropriate Device Problem Term/Code Not Available
SETTING UP AUTOFIX SCREW 2.0. ONE MONTH AFTER APPEARANCE OF AN INFLAMMATORY PHENOMENON WITH REDNESS AND DIGITAL SWELLING IN TWO PATIENTS. INFLAMMATORY REACTION AND LOCAL DISCOMFORT FOR PATIENT PAIN, SWELLING, LOCAL FLUID DRAINAGE.
Patient problems: Erythema; Fluid Discharge; Pain; Swelling
MAUDE report 7993226 ↗
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- NA PIP-10Stryker GmbH · PROSTHESIS, FINGER, CONSTRAINED, POLYMER16 reports
- NA MCP-50Stryker GmbH · PROSTHESIS, FINGER, CONSTRAINED, POLYMER14 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.