MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS PIP UNK

Catalog Number XXX-PIP

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Synovitis (2094); Numbness (2415)

Event Type  Injury  

Event Description

This is the third report of four concerning the same patient.This report concerns the right hand middle finger - proximal pip pyrocarbon implant.It was reported "during my investigation online, i found that your implants may cause synovitis.I experienced this in my right wrist.Therefore, i contacted the doctor who did this surgery and found out these were also ascension.I had the two implants put in pointing and middle finger in the later part of 2009.I began having some problems and went back to the doctor.He said i needed a tenosynovectomy.This was done immediately.He repaired 5 tendons that were to the point of rupture.I still have numbness in the right side on my hand and continuing soreness in my wrist.These implants are still functioning okay but i'm concerned now about the potential for more tendon problems.I would like to know what research has shown on this and long term effects." additional information was received on (b)(6) 2013.It was reported the implant was 'pyrocarbon pip.Additional information was requested by integra, no other information was provided.This is the same patient previously referenced in mfg report numbers 1651501-2013-00036 and 1651501-2013-00037.

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

• Brand Name: PIP UNK
• Type of Device: PIP
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; austin TX 78754
• Manufacturer Contact: caren finkelstein ; 315 enterprise dr; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 3565409
• MDR Text Key: 16054627
• Report Number: 1651501-2013-00048
• Device Sequence Number: 1
• Product Code: NEG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H010005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/13/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-PIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/13/2013
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention