MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC FLATCUT TALAR DOME SZ 3 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 33680033

Device Problems Break (1069); Fracture (1260)

Patient Problems Failure of Implant (1924); Inflammation (1932); Foreign Body In Patient (2687); Implant Pain (4561)

Event Date 12/16/2022

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

It was reported that the patient presented with progressive pain and swelling over one year post-op from infinity total ankle replacement.The physician noticed the broken pegs upon getting a ct for the patient.A revision arthroplasty was performed.During the revision, both the tibial and talar peg were broken off into the patient's bone.

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.¿ the device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Formal medical opinion was sought from an experienced independent medical expert, and he opined that- ¿the pre-(revision)-operative breakage of the tibial peg can neither be confirmed or excluded.The background information to the x-ray is also missing.It is not clear at what time point it has been taken.A thin layer of radiolucency tibial and a very little radiolucency around the talar component is visible.Without further clinical information and without the other plane no sound assessment whether there is loosening or not can be given and even less an answer to the question of what the underlying cause is.¿ more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

It was reported that the patient presented with progressive pain and swelling over one year post-op from infinity total ankle replacement.The physician noticed the broken pegs upon getting a ct for the patient.A revision arthroplasty was performed.During the revision, both the tibial and talar peg were broken off into the patient's bone.

• Brand Name: FLATCUT TALAR DOME SZ 3 INFINITY ADAPTIS
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16141884
• MDR Text Key: 307150994
• Report Number: 3010667733-2023-00017
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889797073073
• UDI-Public: 00889797073073
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 33680033
• Device Catalogue Number: 33680033
• Device Lot Number: 1708414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2021
• 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 Age: 55 YR
• Patient Sex: Male
• Patient Weight: 98 KG