MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE TIBIAL TRAY, LEFT SIZE #5, LEFT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	200252905
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	10/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for evaluation as it remains implanted in the patient.A review of the device history is not possible because the lot number was not communicated.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the patient underwent a total ankle replacement.Allegedly, the patient was experiencing of pain and may need to undergo a revision surgery due to implant loosening.
Additional 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 or Problem 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 TIBIAL TRAY, LEFT SIZE #5, LEFT
• Common Device Name: 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: 15829855
• Report Number: 3010667733-2022-00395
• Device Sequence Number: 5250490
• Product Code: HSN
• UDI-Device Identifier: 00840420124166
• UDI-Public: 00840420124166
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K051023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/31/2022
• Device Model Number: 200252905
• Device Catalogue Number: 200252905
• Device Lot Number: 15378861578135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2022
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 11/19/2022
• Supplement Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown