MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. UNKN PIP IMPL; HIGH DEMAND, REVISION,SEMI-CONSTRAINED,PYROLYTIC CARBON,UNCEMENTEDFINGERPRO

Catalog Number UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Unspecified Infection (1930); Arthralgia (2355); Inadequate Osseointegration (2646)

Event Date 07/01/2014

Event Type  Injury  

Manufacturer Narrative

Internal reference number: (b)(4).Doi: https://doi-org.Ezproxy.Uvm.Edu/10.1177/1753193413479527.This complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from literature sources that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.

Event Description

It was reported that on literature review "ten years¿ experience with a pyrocarbon prosthesis replacing the proximal interphalangeal joint.A prospective clinical and radiographic follow-up", 1 (one) joint from 1 (one) patient suffered from pain and radiographic signs of aseptic loosening after having a pip arthroplasty using the ascension pip pyrocarbon implants.This patient was treated with impaction grafting.Postoperatively, the joint was red and swollen, and an infection was suspected.The prosthesis was explanted after 6 months and the joint was converted into an arthrodesis.The current state of health of the patients is unknown.No further information is available.

• Brand Name: UNKN PIP IMPL
• Type of Device: HIGH DEMAND, REVISION,SEMI-CONSTRAINED,PYROLYTIC CARBON,UNCEMENTEDFINGERPRO
• Manufacturer (Section D): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer (Section G): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16105965
• MDR Text Key: 306787183
• Report Number: 3002788818-2023-00006
• Device Sequence Number: 1
• Product Code: OMX
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other