MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE TIB TRAY RT SZ 5 LNG; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	220222905
Medical Device Problem Codes	Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Cyst(s) (1800); Inadequate Osseointegration (2646)
Date of Event	01/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery because the tibial component since it appears loose and has medial malleolar cyst formation.
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
The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery because the tibial component since it appears loose and has medial malleolar cyst formation.The physician brought the patient to surgery to possibly remove the inbone stem and tibial tray and to remove the talar dome.The tibial stem and tray were solid.The physician used the invision dome and plate.
Additional Manufacturer Narrative
Correction - b2, b5, h6 (device code, results code, conclusion code) the reported event could be confirmed based on available medical record and medical expert assessment.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.The catalog which was originally reported did not match the reported lot, so the catalog has been updated based on the reported lot and the investigation is done based on the catalog corresponding to the reported lot.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Upon further investigation of the ct scans by healthcare professionals the following was observed ¿large cyst in the medial malleolus, patient related bone quality issue¿ based on investigation, the root cause was attributed to a patient related issue.The failure was detected due to large cysts in the medial malleolus and poor bone quality of the patient.According to the hcp, the tibial construct is assessed to be loosened.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: INBONE TIB TRAY RT SZ 5 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: 18783120
• Report Number: 3010667733-2024-00107
• Device Sequence Number: 17271128
• Product Code: HSN
• UDI-Device Identifier: 00840420124296
• UDI-Public: 00840420124296
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/14/2024

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 Catalogue Number: 220222905
• Device Lot Number: 1658594
• 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: 01/31/2024
• Supplement Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2019
• 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; Required Intervention
• Patient Sex: Male