MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE STEM, TIBIAL, TOP SIZE, 14 MM, RIGHT & LEFT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 200011901

Device Problems Inadequacy of Device Shape and/or Size (1583); Migration (4003)

Patient Problems Failure of Implant (1924); Implant Pain (4561)

Event Date 10/25/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent a total ankle replacement.The patient complained of pain.Allegedly, the patient may need to undergo a revision surgery for implant loosening likely caused by patient anatomy.

Manufacturer Narrative

The device is not available for evaluation as it remains implanted in the patient.Once the investigation has been completed any additional information will be reported in a supplemental report.

Manufacturer Narrative

The complaint could be confirmed, since the information for evaluation matches the alleged failure.Medical profession reviewed the received information and noted: left ankle joint, inbone tar in situ.The tibial component consists of the described components: - inbone tibial top stem, inbone tibial base stem, and inbone tibial tray left.All components are intact and there are no signs of component dissociation.The component is surrounded by a radiolucent line, suspect of loosening.There are cystic changes in the adjacent tibial bone.The - inbone poly sz4+ 10mm sulcus looks intact, as far as can be assessed on a ct-scan.The talar component, consisting of inbone talar dome sz4 sulcus, and inbone talar stem are intact without signs of component dissociation.The component has subsided laterally and is surround by significant degenerative bone changes (cysts) in the talus.There are degenerative changes in the adjacent subtalar and talonavicular joints.Whether these are symptomatic cannot be assessed without clinical information.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.Based on investigation, the root cause was attributed to a patient factors issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that the patient underwent a total ankle replacement.The patient complained of pain.Allegedly, the patient may need to undergo a revision surgery for implant loosening likely caused by patient anatomy.

• Brand Name: INBONE STEM, TIBIAL, TOP SIZE, 14 MM, RIGHT & LEFT
• 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: 16057832
• MDR Text Key: 306234616
• Report Number: 3010667733-2022-00475
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00840420123893
• UDI-Public: 00840420123893
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051023
• 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: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 200011901
• Device Catalogue Number: 200011901
• Device Lot Number: 1619682
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2018
• 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): Other