NA PIP-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00886385021577), received between Oct 4, 2019 and Dec 11, 2025 — classified as 13 injuries.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2025Mechanical Problem; Mechanical Problem

  PATIENT REQUIRED SURGERY TO REMOVE AND REPLACE POSSIBLE MALFUNCTION/DEFECTIVE IMPLANT. THE IMPLANT WAS IDENTIFIED AND REMOVED. IT WAS NOTED TO HAVE RUPTURED BETWEEN THE PROXIMAL STEM AND THE BODY OF THE JOINT. THE JOINT HAD BECOME RATHER TIGHT DUE TO THE DISLOCATED IMPLANT AND RELEASE OF THE VOLAR PLATE WAS PERFORMED.

  Patient problems: Failure of Implant

  MAUDE report 23785728 ↗
• InjuryNov 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - MDR - REVISION SURGERY/ REQUIRED INTERVENTION TO PREVENT IMPAIRMENT/DAMAGE.

  Patient problems: Failure of Implant

  MAUDE report 18213160 ↗
• InjuryOct 18, 2023Adverse 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)

  MAUDE report 17962369 ↗
• InjuryDec 26, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "PATIENT PRESENTED WITH A FRACTURED IMPLANT, TOOK OUT FRACTURED IMPLANT AND RE-IMPLANTED NEW ONE."

  Patient problems: Failure of Implant

  MAUDE report 16048851 ↗
• InjuryNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SILICON IMPLANT NEEDED TO BE SWAPPED.

  Patient problems: Insufficient Information

  MAUDE report 15756192 ↗
• InjuryJun 10, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A PIP IMPLANT THAT WAS IMPLANTED ON (B)(6) 2021, FRACTURED WHICH RESULTED IN A REVISION SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 14653767 ↗
• InjuryMay 27, 2021Break; Break

  IT WAS REPORTED THE PATIENT FRACTURED THEIR FINGER, REQUIRING REVISION SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 11895880 ↗
• 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 AND BAD JOINT STABILITY (RADIOGRAPHIC CONTROL- ULNAR OFF-AXIS).

  Patient problems: Joint Laxity; Malunion of Bone

  MAUDE report 10778801 ↗
• 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 (RADIOGRAPHIC CONTROLS-IMPACTION AND ULNAR OFF-AXIS).

  Patient problems: Loss of Range of Motion

  MAUDE report 10778426 ↗
• 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 FOR WHICH TENOARTHROLYSIS WAS DONE LATER.

  Patient problems: Loss of Range of Motion

  MAUDE report 10777927 ↗
• 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 10777794 ↗
• InjuryFeb 3, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT'S HAND (KNUCKLE) WAS REVISED DUE TO THE PIP SILICONE IMPLANT BREAKING. A 40 SILICONE PIP IMPLANT WAS REVISED TO ANOTHER 40 SILICONE PIP IMPLANT.

  Patient problems: Failure of Implant; Injury

  MAUDE report 9659480 ↗
• InjuryOct 4, 2019Degraded; Device Dislodged or Dislocated; Degraded

  A PIP IMPLANT 40 WAS PLACED ON 31 AUGUST 2019. THE CUSTOMER REPORTED THE FOLLOWING: PRIMARY OPERATION DATE: (B)(6) 2018 - PLACEMENT PIP IMPLANT 40. AFTER A WHILE, THE PATIENT WAS HAVING PAIN COMPLAINTS AND THEN AN OPERATION WAS SCHEDULED ((B)(6) 2019). THIS SHOWED THAT THE ORIGINAL IMPLANT WAS NO LONGER INTACT. THERE IS A CONSIDERABLE DEFECT IN THE JOINT OF THE IMPLANT. A NEW PIP IMPLANT HAS BEEN PLACED.

  Patient problems: Injury; Pain

  MAUDE report 9159401 ↗