MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE¿ TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	220223208E
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Deformity/ Disfigurement (2360); Subluxation (4525); Implant Pain (4561)
Date of Event	04/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision surgery in 2014.It is now believed that the patient may have a broken device and is in pain and the ankle is deformed.The doctor recommended not doing anything due to risk of infection and amputation if there is an issue.
Additional Manufacturer Narrative
The device is not available for evaluation as it remains implanted in the patient.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 revision surgery in 2014.It is now believed that the patient may have a broken device and is in pain and the ankle is deformed.The doctor recommended not doing anything due to risk of infection and amputation if there is an issue.
Additional Manufacturer Narrative
Correction - d6a the reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Medical profession reviewed the received information and noted: the x-rays from (b)(6) 2022 show a subluxation (partial dislocation) of the left ankle joint.This has to do with a lack of soft tissue support, creating instability of the left ankle joint.As a result, parts of the talar component articulates with the tibial bone, causing deformation of the bone and the formation of a neo-articulation.In this situation, asymmetrical loading of the polyethylene insert will have damaged this component without doubt.The x-rays from (b)(6) 2022 show that at this moment in time the tibial component is well fixed, as indicated by the bone on growth at the proximal tip of the inbone stem.The tibial device construct looks intact.Still, there is no comparison possible with the initial position of the implant in 2012.So, whether it has subsided cannot be assessed with one moment in time available on x-rays.Without doubt the polyethylene inlay is either deformed or broken or dislodged, or a combination of this.The most posterior one of the talar baseplate fusion rod (500004945) is broken, on the x-rays from (b)(6) 2022.The others are intact, providing enough support to the talar component.Since the fusion rod is crossing the subtalar joint, it can be associated with some residual movement in the subtalar joint, or with some subsidence of the talar component.Still, there is no comparison possible with the initial position of the implant in 2012.So, whether it has subsided cannot be assessed with one moment in time available on x-rays.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 as well as the affected device 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: INBONE¿ TOTAL ANKLE SYSTEM
• 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; 1023 cherry rd; memphis TN 38117
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14287168
• Report Number: 3010667733-2022-00174
• Device Sequence Number: 20185493
• Product Code: HSN
• UDI-Device Identifier: 00840420125002
• UDI-Public: 00840420125002
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K100886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/15/2018
• Device Model Number: 220223208E
• Device Catalogue Number: 220223208E
• Device Lot Number: 1101249825
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/08/2022
• Supplement Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2010
• 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: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 86 KG