NA PIP-30Recalls & reported problems
Stryker GmbH · Silicone PIP Implant Size 30 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker NA PIP-30 is a silicone implant for a finger joint. The 27 reports mostly describe the implant wearing out, loosening, or breaking, and in many cases needing revision surgery; some mention joint laxity, reduced range of motion, infection, or bone loss around the implant. There were27 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00886385021553), received between Oct 22, 2018 and Jan 28, 2025 — classified as 27 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. 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
- Adverse Event Without Identified Device or Use Problem18
- Fracture6
- Break2
- Unstable2
- Biocompatibility1
- Inadequacy of Device Shape and/or Size1
- Naturally Worn1
Patient problems
- Failure of Implant9
- Joint Laxity6
- Insufficient Information5
- Loss of Range of Motion4
- Unspecified Infection3
- Osteolysis2
- Arthralgia1
- Bone Fracture(s)1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 12, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryOct 29, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - INSTABILITY.
Patient problems: Insufficient Information; Joint Laxity; Metal Related Pathology
MAUDE report 20563710 ↗InjuryMay 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO FRACTURE.
Patient problems: Bone Fracture(s); Limb Fracture
MAUDE report 19294252 ↗InjuryApr 11, 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 19093729 ↗InjuryApr 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY ,DUE TO IMPLANT FAILURE.
Patient problems: Failure of Implant
MAUDE report 16773679 ↗InjuryMar 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 22, 2022Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE PATIENT FRACTURED THE IMPLANT, RESULTING IN A REVISION SURGERY.
Patient problems: Failure of Implant
MAUDE report 15842605 ↗InjuryJun 27, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
AS REPORTED: "IMPLANT WAS TOO BIG. REPLACED WITH PIP-20".
Patient problems: Insufficient Information
MAUDE report 14830619 ↗InjuryNov 29, 2021Break; Fracture; Break; Fracture
THE CUSTOMER REPORTED THE FOLLOWING ISSUE: "SILICONE IMPLANT BROKE OFF, CAUSING FINGER TO DISLOCATE. THE PATIENT REQUIRED A REVISION SURGERY."
Patient problems: Failure of Implant; Joint Dislocation
MAUDE report 12882905 ↗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 12793183 ↗InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: REVISION OF PIP ARTHROPLASTY DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 12187237 ↗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 10780104 ↗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 SMALL ULNAR OFF-AXIS.
Patient problems: Insufficient Information
MAUDE report 10779975 ↗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 SMALL ULNAR OFF-AXIS.
Patient problems: Insufficient Information
MAUDE report 10779864 ↗InjuryNov 3, 2020Biocompatibility; Biocompatibility
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 SILICONITE -SILICON REACTIVE SYNOVITIS (RADIOGRAPHIC CONTROL- GEODE) WHICH WAS NOT FURTHER SURGICAL TREATED. A MEDICAL APPROACH HAS BEEN SUCCESSFUL. (NOT A PROPER ALLERGY TO SILICONE, BUT MORE OF AN INTOLERANCE).
Patient problems: Synovitis
MAUDE report 10779027 ↗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 (RADIOGRAPHIC CONTROL- ULNAR OFF-AXIS AND IMPACTION).
Patient problems: Malunion of Bone
MAUDE report 10778902 ↗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 BAD JOINT STABILITY AND INFECTION WHICH WAS TREATED WITHOUT THE NEED TO REMOVE THE IMPLANT (RADIOGRAPHIC CONTROL- ULNAR OFF-AXIS, OSTEOLYSIS).
Patient problems: Joint Laxity; Osteolysis; Unspecified Infection
MAUDE report 10778802 ↗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 WHICH WAS LATER AMPUTATED DUE TO TENDENCY OF THE PATIENT TO DEVELOP STIFFNESS. THE REPORT STATES ¿PRIMARY INDICATION FOR SURGERY: STIFFNESS AS SIDE EFFECT OF PREVIOUS TENOARTHROLYSIS¿.
Patient problems: Loss of Range of Motion
MAUDE report 10778428 ↗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 STIFFNESS FOR WHICH TENOARTHROLYSIS WAS DONE LATER.
Patient problems: Loss of Range of Motion
MAUDE report 10777928 ↗InjuryNov 3, 2020Fracture; Fracture
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 BAD JOINT STABILITY AND RUPTURE OF PIP ON D3 (RADIOGRAPHIC CONTROL-ULNAR OFF-AXIS, RUPTURE) WHICH WILL BE REIMPLANTED. THE REPORT STATES: ¿IN THE LAST CASE, THE PATIENT, IMPLANTED ON PIP OF D2 AND D3, PRESENTED 39 MONTHS LATER WITH OSTEOARTHRITIS ON D4 (TREATED WITHOUT SURGERY), AND THE DIAGNOSIS OF THE RUPTURE ON D2 AND D3 WAS
Patient problems: Failure of Implant; Joint Laxity
MAUDE report 10777704 ↗InjuryNov 3, 2020Fracture; Fracture
THE MANUFACTURER BECAME AWARE OF A POST MARKET CLINICAL FOLLOW-UP REPORT RECEIVED FROM (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 BAD JOINT STABILITY AND RUPTURE OF PIP ON D2 (RADIOGRAPHIC CONTROL-ULNAR OFF-AXIS, RUPTURE) WHICH WILL BE REIMPLANTED. THE REPORT STATES: ¿IN THE LAST CASE, THE PATIENT, IMPLANTED ON PIP OF D2 AND D3, PRESENTED 39 MONTHS LATER WITH OSTEOARTHRITIS ON D4 (TREATED WITHOUT SURGERY), AND THE DIAGNOSIS OF THE RUPTURE ON D2 AND D3 WAS THEREFORE ESTABLISHED BY CHANCE. THE PATIENT, CO
Patient problems: Failure of Implant; Joint Laxity
MAUDE report 10777702 ↗InjuryNov 3, 2020Fracture; Fracture
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 RUPTURE DIAGNOSED 45 MONTHS AFTER THE FIRST IMPLANTATION ALONG WITH A DRASTIC REDUCTION IN RANGE OF MOTION AND A HIGH ANALGESIC INDEX (RADIOGRAPHIC CONTROL-IMPACTION AND REDUCED SPACING) WHICH WAS REIMPLANTED ON (B)(6) 2018. THE REPORT STATES: ¿IN THIS FIRST CASE, DURING A SINGLE IMPLANTATION ON A D4 PIP, THE PATIENT WAS DIAGNOS
Patient problems: Failure of Implant; Loss of Range of Motion
MAUDE report 10777635 ↗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 INFECTION WHICH HEALED WITHOUT HAVING TO CHANGE THE IMPLANT (RADIOGRAPHIC CONTROL- OSTEOLYSIS) THE REPORT STATES: ¿IN THIS FIRST CASE, DURING A SINGLE IMPLANTATION ON A D4 PIP, THE PATIENT WAS DIAGNOSED WITH A PROSTHESIS RUPTURE 45 MONTHS AFTER THE FIRST IMPLANTATION. THE PATIENT PRESENTED WITH A DRASTIC REDUCTION IN RANGE OF MO
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 10777633 ↗
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-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
- NA PIP-40Stryker 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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page