MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. UNKN PIP IMPL; HIGH DEMAND, REVISION, SEMI-CONSTR, PYROLYTIC CARBON, UNCEMENTED FINGER PROSTH

Catalog Number UNKN2400503

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

Patient Problem Joint Contracture (4528)

Event Date 03/01/2022

Event Type  Injury  

Event Description

It was reported that on literature review "pyrolytic carbon arthroplasty for the proximal interphalangeal joint: results after minimum 3 years of follow-up", a total of sixteen (16) patients underwent pip joint replacement using a pyrocarbon implant to address arthritis symptoms.From these, five (5) patients sustained a flexion contracture and stiffness for which a tenoarthrolysis was medically indicated.Three (3) of these patients underwent this surgery to try and improve the range of motion, but the other two (2) declined further surgery.The arc of motion improved by 43 degrees in one finger (from 8-25 degrees preoperatively to 5-65 degrees postoperatively) and by 36 degrees in another finger (from 10-26 degrees preoperatively to 0-52 degrees postoperatively), while in the remaining patient there was a slight loss of mobility.No further information is available.

Manufacturer Narrative

Literature citation: pyrolytic carbon arthroplasty for the proximal interphalangeal joint: results after minimum 3 years of follow-up.Doi: 10.1177/1753193412443044.Initial/final mdr.Internal reference: (b)(4).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.

• Brand Name: UNKN PIP IMPL
• Type of Device: HIGH DEMAND, REVISION, SEMI-CONSTR, PYROLYTIC CARBON, UNCEMENTED FINGER PROSTH
• 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: 15843485
• MDR Text Key: 304098821
• Report Number: 3002788818-2022-00114
• Device Sequence Number: 1
• Product Code: OMX
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN2400503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1