MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE TIB TRAY LEFT SZ 2 LNG; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	220220901
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a total ankle replacement.Allegedly, the patient may need to undergo a revision surgery for reasons that are not available at the time of this report.
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed. a review of the device history is not possible because the lot number was not communicated. should additional information become available, it will be provided on a supplemental report.Device remains implanted in patient.
Event or Problem Description
It was reported that the patient underwent a total ankle replacement.Allegedly, the patient may need to undergo a revision surgery for reasons that are not available at the time of this report.
Additional Manufacturer Narrative
Correction - h6 device code and h6 results code the reported event could be confirmed, since imaging provided indicates loosening of the tibial component and subsidence of the talar component.Medical affairs was consulted on this case.According to their review of the available information, "the two ct-slices show a clear loosening of the tibial component, indicated by a radiolucent zone around the component, flanked by a sclerotic line.The talar component has subsided." also, "since the ct-images show a clear loosening of the tibial component, and subsidence of the talar component, the patient may complaint about pain and loss of function.Also, the imaging is indicative for a low grade periprosthetic joint infection (the sclerotic line can be response to create a line of a defense thrown up by the bone to prevent the infection from spreading further into the bone).To confirm symptomatic loosening and/or periprosthetic joint infection, clinical information is necessary.This is not available now." 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 was not possible because the lot number was not communicated.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 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.Allegedly, the patient may need to undergo a revision surgery for reasons that are not available at the time of this report.
Additional Manufacturer Narrative
Correction - d1, d4 (catalog#), gtin, g4, h6 (health impact code, results code) the reported event could be confirmed based on information provided that indicates a gutter debridement was performed and imaging and information from the initial reporter indicated slight subsidence of the tibial tray.Medical affairs was consulted on this case.According to their review of the available information, regarding the tibial tray & stem construct "there is some subsidence without signs of loosening of the prosthesis." also, "since the ct-images show no clear loosening, intraoperative findings and implant retrieval may be helpful to assess the root cause.The implant as such looks in order, assessment of the pe-liner can best be done on the retrieved component." it was noted the tibial construct and talar dome were not explanted as there were not signs of loosening intraoperatively.A gutter debridement was performed with a poly swap.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 was not possible because the lot number was not communicated.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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: INBONE TIB TRAY LEFT SZ 2 LNG
• 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: 14686146
• Report Number: 3010667733-2022-00208
• Device Sequence Number: 4635752
• Product Code: HSN
• UDI-Device Identifier: 00840420124302
• UDI-Public: 00840420124302
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K100886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: 220220901
• Device Catalogue Number: 220252902
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2022
• Supplement Date Received by Manufacturer: 08/18/2022; 10/25/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 09/12/2022; 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Male