MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TALDOME SZ2 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33680022
Medical Device Problem Codes	Osseointegration Problem (3003); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Implant Pain (4561)
Date of Event	08/21/2023
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.
Event or Problem Description
The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery due to continued pain for two years since the implant procedure.The physician presumes loosening with associated pain.
Event or Problem Description
The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery due to continued pain for two years since the implant procedure.The physician presumes loosening with associated pain.
Additional Manufacturer Narrative
The reported event could be confirmed, based on available medical records and medical expert¿s 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.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 "the tibial component does show radiolucence at the very anterior end.There, a loosening is possible, although the rest of the component seems to be integrated within the underlying spongious bone.The pe cannot be assessed directly, however, there is no clear indirect sign of loosening or fracture visible.The talar component shows some artefacts and there is a little bit of radiolucence visible.Together with the given clinical information to this case, this could be interpreted as loosening at least.A talo-calcaneal arthrodesis is also visible.Poor bone stock or insufficient metabolism (vascular status?) could have been potential patient related issues.Obvious surgical omissions are not visible.With the given information confirmation is not possible.The images are not clear and the assessment relies on the hcps answer that aseptic loosening in the talus and tibia are likely.Insufficient information would also be a potential information.On the other hand the surgeon describes a loosening and there is no obvious imaging that would contradict this assessment." based on investigation, the root cause was attributed to a patient related issue.The failure was caused most likely by poor bone stock of patient if device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: INFINITY ADAPTIS TALDOME SZ2 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: 17757701
• Report Number: 3010667733-2023-00536
• Device Sequence Number: 17806014
• Product Code: HSN
• UDI-Device Identifier: 00889797101523
• UDI-Public: 00889797101523
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K172633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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 Catalogue Number: 33680022
• Device Lot Number: 1705798
• 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: 08/21/2023
• Supplement Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2021
• 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