MAUDE Adverse Event Report: STRYKER CORP. STRYKER PIP ARTHROPLASTY SIZES 2 AT INDEX 20MM SCREW; SEMI-CONTRAINED METAL/POLYMER FINGER JOINT PROSTHESIS

Device Problems Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Nerve Damage (1979); Pain (1994); Joint Dislocation (2374); Osteolysis (2377)

Event Date 01/21/2016

Event Type  Injury  

Event Description

(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.

• Brand Name: STRYKER PIP ARTHROPLASTY SIZES 2 AT INDEX 20MM SCREW
• Type of Device: SEMI-CONTRAINED METAL/POLYMER FINGER JOINT PROSTHESIS
• Manufacturer (Section D): STRYKER CORP.
• MDR Report Key: 8416501
• MDR Text Key: 138771536
• Report Number: MW5084860
• Device Sequence Number: 1
• 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
• Report Date: 03/11/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 71 YR
• Patient Weight: 61