MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS FGT IMPLANT SIZE 20; TOE JOINT REPLACEMENT

Catalog Number FGT-20T

Device Problem Crack (1135)

Patient Problem Injury (2348)

Event Date 08/05/2020

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A physician reported a toe joint replacement implant ¿crack¿: the implant was placed on right great toe on (b)(6) 2020.Patient had a cheilectomy before this surgery.The implant was removed on (b)(6) 2020 and it had a crack/cut through silicone portion of flexible joint.Surgeon believes remaining bone spurs damaged the implant and caused it to fail.He is an experienced surgeon on this product and has never seen this type of result.He believes the issue was biologic and not the result of a faulty implant.He has no issues with the implant¿s performance.

Event Description

N/a.

Manufacturer Narrative

Updated fields - d10, g4, g7, h2, h3, h6, h10.Udi: (b)(4).Additional information received: patient had previous cheilectomy and that there were no traumatic or contributing events prior to the discovery of the issue.The implant was removed because it was cracked and damaged, replaced by a new fgt implant.The patient have experienced general discomfort due to implant failure.The implant was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h6, h10.The following was not included in follow up #1: product not received for evaluation, but photographs were provided.Photographs of the explanted device show cracking at the device joint when the device is flexed.The failure is confirmed.

Event Description

N/a.

• Brand Name: FGT IMPLANT SIZE 20
• Type of Device: TOE JOINT REPLACEMENT
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX 78754
• MDR Report Key: 10480223
• MDR Text Key: 205271209
• Report Number: 1651501-2020-00016
• Device Sequence Number: 1
• Product Code: KWH
• Combination Product (y/n): N
• PMA/PMN Number: K981194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: FGT-20T
• Device Lot Number: CT0115126
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 09/08/2020; 04/21/2021
• Supplement Dates FDA Received: 09/23/2020; 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR