MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TIB SZ3 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33680003
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Cyst(s) (1800); Joint Dislocation (2374); Inadequate Osseointegration (2646); Implant Pain (4561)
Date of Event	01/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned as it remains implanted in the patient.When additional information becomes available, it will be provided on a supplemental report.H3 other text : device remains implanted in patient.
Event or Problem Description
It was reported that the patient may need to undergo a revision surgery due to a loose/painful tibia implant.If they switch to a stemmed implant on the tibia then the talar component must also be removed as a result.
Additional Manufacturer Narrative
The reported event could be confirmed, based on available ct scans and healthcare expert opinion.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.Upon further investigation of the ct scans by healthcare professionals the following was observed tibial (construct):there is radiolucence and there are large cysts around the tibial tray.The implant is loosened and posteriorly dislocated/migrated proximally.Pe: the pe is not separated from the tibial component.There is no clear sign of loosening or breakage.Talar (construct): the talar component shows radiolucence and the component seems posteriorly dislocated.Therefore, loosening and migration seem likely.Full tar (construct): there is a little chance, that the talar implant was already positioned so far posterior-at least the hcp does not refer to a loosening of the talar component, but in my opinion the component is secondarily dislocated.Based on investigation, the root cause was attributed to a patient related issue.The failure is detected by the radiolucence and large cyst around both tibial and talar components.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
It was reported that the patient may need to undergo a revision surgery due to a loose/painful tibia implant.If they switch to a stemmed implant on the tibia then the talar component must also be removed as a result.

• Brand Name: INFINITY ADAPTIS TIB SZ3 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: 18722440
• Report Number: 3010667733-2024-00075
• Device Sequence Number: 20284962
• Product Code: HSN
• UDI-Device Identifier: 00889797069656
• UDI-Public: 00889797069656
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K181557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2024

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: 33680003
• Device Lot Number: 1743881
• 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: 01/22/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2022
• 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