STRYKER PIP ARTHROPLASTY SIZES 2 AT INDEX 20MM SCREW

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-12 for STRYKER PIP ARTHROPLASTY SIZES 2 AT INDEX 20MM SCREW manufactured by Stryker Corp..

Event Text Entries

[138771536] (b)(6) clinic (b)(6) installed three titanium finger joints in my left hand due to osteoarthritis detonation ((b)(6) 2016). All three joints have failed. Titanium is destroying bone matter. Joints come out of sockets, are loose in the bone and i have swan neck deformity. I complained to (b)(6) clinic within a month of the surgery and was given lip service. I have had a secondary remedial surgery (tendon tightening) on two fingers to prevent joints from either falling out of sockets and/or swan neck deformity. Continual pain, bone degeneration and lack of mobility are now everyday occurrences. Metal is stronger than bone and the metal is destroying the fingers. Dr. (b)(6) of (b)(6) made diagnosis and recommended the replacements. He said he would do the surgery but it was done by a resident. Saw (b)(6) at time of diagnosis and at time of surgery and never again. Always referred to a p. A. Dr. (b)(6) always cancelled my post-operative visits days before me coming to clinic. I have nerve damage in one finger, have had a significant loss of sensation, as well as swan neck deformity. All of these matters reported to (b)(6) within one week of surgery. Remedial surgery performed in (b)(6) on (b)(6) 2018 by (b)(6) orthopedic surgeon. Goal of surgery was to prevent joints from falling out of sockets and limit swan neck deformity. (b)(6) dr. Informed me the joints were not fda approved, did not tell me that bone damage could result from the implants, and they refused to address the swan neck and nerve damage. (b)(6) dr. Said joints will eventually have to be removed. Then what? Titanium joints have destroyed so much bone that fusion is not possible. Please help. I now wear a brace on my middle finger 24/7, these titanium joints are a disaster.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5084860
MDR Report Key8416501
Date Received2019-03-12
Date of Report2019-03-11
Date of Event2016-01-21
Date Added to Maude2019-03-13
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 1

Brand NameSTRYKER PIP ARTHROPLASTY SIZES 2 AT INDEX 20MM SCREW
Generic NameSEMI-CONTRAINED METAL/POLYMER FINGER JOINT PROSTHESIS
Product CodeMPK
Date Received2019-03-12
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER CORP.

Device Sequence Number: 2

Brand NameSTRYKER PIP ARTHROPLASTY SIZE 3 AT LONG 20MM SCREW
Generic NameSEMI-CONSTRAINED METAL/POLYMER FINGER JOINT PROSTHESIS
Product CodeMPK
Date Received2019-03-12
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerSTRYKER CORP.

Device Sequence Number: 3

Brand NameSTRYKER PIP ARTHROPLASTY SIZE 2 RING 20MM SCREW
Generic NameSEMI-CONSTRAINED METAL/POLYMER FINGER JOINT PROSTHESIS
Product CodeMPK
Date Received2019-03-12
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No3
Device Event Key0
ManufacturerSTRYKER CORP.


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention; 2. Deathisabilit 2019-03-12

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