MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE TALAR DOME SZ 3 SULCUS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	220220903
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Insufficient Information (4580)
Date of Event	08/29/2022
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.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.
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
The reported event could be confirmed with the help of medical documents provided for investigation.The device inspection was not possible as the product was not returned 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.Formal medical opinion was sought from an experienced independent medical expert for the available information and he opined that- ¿the ct-scan of this case shows subsidence of the tibial component in a varus position and marked posterior subsidence.There are no signs of problems with the pe-liner, but a retrieval is necessary to make that implication definitive.There are several degenerative cysts below the talar component as a part of wide-spread degenerative changes of the foot skeleton.¿ based on the medical expert opinion, the cause of the revision can be attributed to patient-related.¿there are several degenerative cysts below the talar component as a part of wide-spread degenerative changes of the foot skeleton.¿ if device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: INBONE TALAR DOME SZ 3 SULCUS
• 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: 15480597
• Report Number: 3010667733-2022-00319
• Device Sequence Number: 15203355
• Product Code: HSN
• UDI-Device Identifier: 00840420124227
• UDI-Public: 00840420124227
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2023

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: 06/19/2026
• Device Model Number: 220220903
• Device Catalogue Number: 220220903
• Device Lot Number: 1618653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/29/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2018
• 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: Unknown