MAUDE Adverse Event Report: STRYKER GMBH STRYKER PIP #2, #3; SEMI-CONSTRAINED METAL/POLYMER FINGER JOINT PROSTHESIS

Model Number PIP

Device Problems Device Slipped (1584); Device Dislodged or Dislocated (2923)

Patient Problems Nerve Damage (1979); Pain (1994); Swelling (2091); Discomfort (2330); Numbness (2415)

Event Date 01/21/2016

Event Type  Injury  

Event Description

Doctor (b)(6) of (b)(6) recommended stryker pip implants for my left index proximal, left index distal and left long finger.Implants put in on (b)(6) 2016 immediate swan neck deformity on middle finger and long finger.Finger next to thumb implant has loosened.Middle finger came out of joint (dislocated).3 times.Finger next to pinky.Severe swan neck syndrome.Other joint loose in place.Remedial surgery on (b)(6) 2018 to shorted tendons to prevent dislocations and swan neck.Must wear brace 24/7 on middle finger.Much pain/discomfort/nerve damage.Immediately post operative exam showed swan neck.Deformity on middle and ring finger as well as numbness in ring finger.Pain has been constant, as has stiffness.Post operative concerns voiced to (b)(6) to no avail.Eventually, pain increased, joint would dislocate.Finger next to thumb swollen, joint (stryker) loose.Xrays show significant bone loss due to implant being harder than bone and bone being destroyed at all implant locations.Bone at all implant sites is deteriorating.

• Brand Name: STRYKER PIP #2, #3
• Type of Device: SEMI-CONSTRAINED METAL/POLYMER FINGER JOINT PROSTHESIS
• Manufacturer (Section D): STRYKER GMBH
• MDR Report Key: 8459729
• MDR Text Key: 140312117
• Report Number: MW5085250
• Device Sequence Number: 2
• Product Code: MPK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PIP
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/27/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 61