MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC FLAT CUT TALAR DOME SZ 2 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 33680032

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

Patient Problems Unspecified Infection (1930); Fluid Discharge (2686); Implant Pain (4561); Swelling/ Edema (4577)

Event Date 06/03/2021

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.H3 other text : device not available.

Event Description

It was reported that the patient underwent a revision surgery due to pain, drainage and swelling.The patient had septic arthritis in the ankle due to an unspecified organism.The implants were removed and an antibiotic spacer was implanted.

Event Description

It was reported that the patient underwent a revision surgery due to pain, drainage and swelling.The patient had septic arthritis in the ankle due to an unspecified organism.The implants were removed and an antibiotic spacer was implanted.

Manufacturer Narrative

The complaint couldn't be confirmed, since the device was not returned for evaluation and no other evidences were provided, to confirm the reported infection.Microbiologist reviewed the sterility of the dhr and noted: the subject device was packaged according to established design and process specifications, and got sterilized acording to process.No deviation for a non-conformance could be found.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: FLAT CUT TALAR DOME SZ 2 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: 17962349
• MDR Text Key: 326004201
• Report Number: 3010667733-2023-00611
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889797073066
• UDI-Public: 00889797073066
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 33680032
• Device Lot Number: 1688336
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 10/18/2023
• Supplement Dates Manufacturer Received: 11/20/2023
• Supplement Dates FDA Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2020
• 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: 45 YR
• Patient Sex: Female
• Patient Weight: 123 KG