MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC FLATCUT TALAR DOME SZ 4 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 33680034

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

Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735); Purulent Discharge (1812); Swelling/ Edema (4577)

Event Date 05/09/2022

Event Type  Injury  

Event Description

It was reported that the patient presented to the clinic on (b)(6) 2022, concerned about an infection of the anterior ankle incision.The physician noted a surgical wound complicated by dehiscence, drainage of purulent fluid, swelling, and erythema.Following a right ankle wound irrigation and debridement on (b)(6) 2022, the physician noted no evidence of a deep infection.Routine culture final report on (b)(6) 2022, confirmed a staphylococcus aureus infection.Patient was prescribed keflex.

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided on a supplemental report.

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Infections are often caused by a multitude of factors such as comorbidity of the patient, the trauma, the surgical intervention and the aftercare.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.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.If more information is provided, the case will be reassessed.

Event Description

It was reported that the patient presented to the clinic on (b)(6) 2022, concerned about an infection of the anterior ankle incision.The physician noted a surgical wound complicated by dehiscence, drainage of purulent fluid, swelling, and erythema.Following a right ankle wound irrigation and debridement on (b)(6) 2022, the physician noted no evidence of a deep infection.Routine culture final report on (b)(6) 2022, confirmed a staphylococcus aureus infection.Patient was prescribed keflex.

• Brand Name: FLATCUT TALAR DOME SZ 4 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: 15463627
• MDR Text Key: 300374341
• Report Number: 3010667733-2022-00313
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889797073080
• UDI-Public: 00889797073080
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2022

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 Model Number: 33680034
• Device Catalogue Number: 33680034
• Device Lot Number: 1719635
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2022
• Initial Date FDA Received: 09/22/2022
• Supplement Dates Manufacturer Received: 10/07/2022
• Supplement Dates FDA Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2022
• 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 Age: 61 YR
• Patient Sex: Male
• Patient Weight: 111 KG