MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TALDOME SZ1 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33680021
Medical Device Problem Codes	Break (1069); Fracture (1260); Device Dislodged or Dislocated (2923); Osseointegration Problem (3003); Migration (4003)
Health Effect - Clinical Codes	Cyst(s) (1800); Failure of Implant (1924); Joint Dislocation (2374); Inadequate Osseointegration (2646)
Date of Event	02/05/2024
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 due to possible fracture of the posterior tibia peg and/or talar pegs.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.H3 other text : device remains implanted in patient.
Additional Manufacturer Narrative
Correction - h6 (clinical signs code, device code) the reported event could be confirmed, based on available medical records and health care professionals.The evaluation of ct scans by our medical affairs could not confirm the device pegs was broken.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.A review of the labeling did not indicate any abnormalities.Upon further investigation of the ct scans by healthcare professionals the following was observed: after reviewing hcp opinion and surgeon¿s feedback we can conclude that the tibial component shows some radiolucence and some cysts.Component is dislocated.Loosening and migration could be confirmed.Pe seems attached with components, no sign of breakage or separation.The talar component shows some radiolucence and some artifacts which do not allow clear assessment of pegs.Loosening and migration anteriorly could be confirmed.Based on investigation, the root cause was attributed to a patient related issue.The failure is detected by the radiolucence and migration of tibial and talar component.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery due to possible fracture of the posterior tibia peg and/or talar pegs.

• Brand Name: INFINITY ADAPTIS TALDOME SZ1 INFINITY ADAPTIS
• 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: 18813303
• Report Number: 3010667733-2024-00132
• Device Sequence Number: 4319746
• Product Code: HSN
• UDI-Device Identifier: 00889797101516
• UDI-Public: 00889797101516
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K172633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/03/2026
• Device Catalogue Number: 33680021
• Device Lot Number: 1639399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2018
• 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: Other
• Patient Sex: Female