NA PIP-10Recalls & reported problems
Stryker GmbH · Silicone PIP Implant Size 10 · 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 00886385021515), received between Sep 25, 2020 and Oct 20, 2025 — classified as 16 injuries.
The most frequently reported specific device problem is “Fracture” (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 Problem10
- Fracture4
- Device Dislodged or Dislocated1
- Naturally Worn1
- Patient Device Interaction Problem1
- Unstable1
Patient problems
- Failure of Implant7
- Loss of Range of Motion4
- Joint Laxity3
- Insufficient Information2
- Bone Fracture(s)1
- Hypersensitivity/Allergic reaction1
- Joint Dislocation1
- Malunion of Bone1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
InjuryOct 20, 2025Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION SURGERY TO REPLACE BROKEN SILICONE IMPLANT.
Patient problems: Bone Fracture(s); Insufficient Information
MAUDE report 23343465 ↗InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
InjuryMay 1, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO SOFT TISSUE TENSION TOO TIGHT PREVENTING THE PATIENT FROM FLEXING.
Patient problems: Loss of Range of Motion
MAUDE report 20500970 ↗InjurySep 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RIVISION SURGERY - DUE TO IMPLANT FAILURE.
Patient problems: Failure of Implant
MAUDE report 20218978 ↗InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO IMPLANT FAILED/REQUIRED INTERVENTION TO PREVENT IMPAIRMENT/DAMAGE.
Patient problems: Failure of Implant
MAUDE report 16309280 ↗InjuryJun 13, 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 DIFFICULTY IN THE JOINT MOVEMENT.
Patient problems: Loss of Range of Motion
MAUDE report 14674152 ↗InjuryFeb 22, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
AS REPORTED: "WOMAN DISLOCATED FINGER BETWEEN 2-6 WEEKS POST OP. NO PROBLEM WITH IMPLANT. " REVISION SURGERY PERFORMED.
Patient problems: Joint Dislocation
MAUDE report 13582003 ↗InjuryNov 11, 2021Naturally Worn; Naturally Worn
AS REPORTED; "IMPLANTS WORE APART WITHIN THE PATIENTS PIP JOINT CAUSING A LOSS IN RANGE OF MOTION. INITIAL PRIMARY SURGERY PROVIDED SHORT TERM RELIEF BUT BECAUSE OF HOW THEY WERE IMPLANTED THE PATIENT LOST RANGE OF MOTION OVER TIME AS SILICON REPLACEMENT WORE OUT."
Patient problems: Failure of Implant; Loss of Range of Motion
MAUDE report 12793172 ↗InjurySep 6, 2021Fracture; Fracture
IT WAS REPORTED THE IMPLANT BROKE; IT NEEDED TO BE REMOVED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 12428684 ↗InjuryMay 4, 2021Fracture; Fracture
AS REPORTED: "BROKEN PIP RESULTED IN REVISION SURGERY".
Patient problems: Failure of Implant
MAUDE report 11773144 ↗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 ULNAR OFF-AXIS.
Patient problems: Insufficient Information
MAUDE report 10780145 ↗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 DESAXATION (BONE MISALIGNMENT) AND BAD JOINT STABILITY (RADIOGRAPHIC CONTROL- IMPACTION, ULNAR OFF-AXIS).
Patient problems: Joint Laxity; Malunion of Bone
MAUDE report 10779164 ↗InjuryNov 3, 2020Fracture; Fracture
THE MANUFACTURER BECAME AWARE OF A POST MARKET CLINICAL FOLLOW-UP REPORT RECEIVED FROM URGENCE MAIN (B)(6). 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 RUPTURE DIAGNOSED AFTER 59 MONTHS ALONG WITH A RELATIVELY SUDDEN DECREASE IN RANGE OF MOTION WITHOUT PAIN (RADIOGRAPHIC CONTROL-REDUCED SPACING) WHICH WAS RE-IMPLANTED ON (B)(6) 2014. THE REPORT STATES: ¿FOR THE THIRD PATIENT, THE FIRST IMPLANTATION WAS PERFORMED ON A PIP OF D2, AND THE DIAGNOSIS OF RUPTURE WAS MADE AFTER 59 MONTHS. THE PATIENT CAME TO THE CLINIC
Patient problems: Failure of Implant; Loss of Range of Motion
MAUDE report 10777636 ↗InjurySep 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ALLERGY WAS REPORTED AFTER IMPLANTATION.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 10587106 ↗
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 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.
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