MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. UNKN PIP IMPL; HIGH DEMAND, REVISION, SEMI-CONSTRAINED, PYROLYTIC CARB, UNCEMENTED FINGER PROS

Catalog Number UNKNOWN

Device Problems Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Erosion (1750); Joint Dislocation (2374)

Event Date 05/01/2012

Event Type  Injury  

Event Description

It was reported that on literature review "outcomes of pyrolytic carbon arthroplasty for the proximal interphalangeal joint at 44 months mean follow-up", forty six (24) months after a pipj joint replacement surgery on one (1) patient's left long finger, the patient experienced a dislocation.Also, the implant exhibited irregular periprosthetic lucency of >0.5 mm at the time of the final follow-up.The dislocation was managed conservatively by dorsal blocking splinting.Patient's outcome is unknown.No further information is available.

Manufacturer Narrative

Initial / final mdr.Internal reference number: (b)(4).Ono s, shauver mj, chang kwc, chung kc.Outcomes of pyrolytic carbon arthroplasty for the proximal interphalangeal joint at 44 months' mean follow-up.Plast reconstr surg.2012 may;129(5):1139-1150.Doi: 10.1097/prs.0b013e31824a2e38.Pmid: 22261566; pmcid: pmc3341519.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-CONSTRAINED, PYROLYTIC CARB, UNCEMENTED FINGER PROS
• 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: 15944061
• MDR Text Key: 305145363
• Report Number: 3002788818-2022-00163
• Device Sequence Number: 1
• Product Code: OMX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2022
• 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
• Patient Sex: Female