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

Model Number	200220903
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	11/12/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 3 years post-op the patient underwent a revision for a poly exchange and talar tray exchange with talar rebuild due to talar tray subsidence and degradation of the posterior talus.2 rods were also added during the revision surgery.
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.
Event or Problem Description
It was reported that 3 years post-op the patient underwent a revision for a poly exchange and talar tray exchange with talar rebuild due to talar tray subsidence and degradation of the posterior talus.(b)(4) rods were also added during the revision surgery.
Additional Manufacturer Narrative
Correction h6 method code, result code.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The reported event could be confirmed, since medical records provided indicate the patient presented with pain in the posterior ankle joint and decreased range of motion and the reason for revision to be talar dome subsidence and talar degredation.Although the event could be confirmed, the root cause is undetermined due to lack of detailed clinical information for review.Information provided indicated the patient had an extensive surgical history in the left ankle.An original surgery was performed to add unknown screws in 2009 and a procedure to convert to a total ankle arthroplasty in 2010.The patient had a history of left ankle degenerative joint disease with mild valgus, pain in left ankle with significant deformity in that region.Pathology lab notes from 2010 procedure state: bone, talar joint: fragments of bone with attached articular cartilage exhibiting osteoarthritis.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 the device is returned or if any additional information is provided, the investigation will be reassessed.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition unknown.

• 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.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14360426
• Report Number: 3010667733-2022-00181
• Device Sequence Number: 17370257
• Product Code: HSN
• UDI-Device Identifier: 00840420124043
• UDI-Public: 00840420124043
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K051023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2022

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: 08/01/2017
• Device Model Number: 200220903
• Device Catalogue Number: 200220903
• Device Lot Number: 089849855
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2022
• Supplement Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 86 KG