MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN STRYKER PIP IMPLANT

Catalog Number UNK_SEL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nerve Damage (1979); Pain (1994); Joint Dislocation (2374); Numbness (2415)

Event Date 01/21/2016

Event Type  Injury  

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned, and no other evidence was provided.A device inspection was not possible since the affected device was not returned, and no other evidence was provided for investigation.The batch record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, based on past complaint history and risk management file one of the probable causes of the failure could be misinterpretation of the warnings and precautions stated in the product insert and surgical technique permitting the patient to participate in excessive physical activity and/or demonstrates compliance inconsistent with acceptable post-operative care.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device disposition unknown.

Event Description

Review of maude database revealed report # mw5085250 which stated the following: 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: UNKNOWN STRYKER PIP IMPLANT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: kevin smith ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10077271
• MDR Text Key: 191705417
• Report Number: 0008031020-2020-01521
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention