MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TIB SZ4LNG INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33680014
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Cyst(s) (1800); Inadequate Osseointegration (2646)
Date of Event	06/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in 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 loose tibia.There is slight bone loss and cystic changes noted on ct scans.The physicians plans to revise both the tibial and talar components.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.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, healthcare professionals opined that- ¿the surgeons note on the tibia can be confirmed with the attached ct scan.There are cysts and radiolucence at the tibial component.Together with the clinical information loosening can be confirmed.There is no significant migration, though.The talar component has a little bit of radiolucence around the pegs, but neither loosening nor migration is clearly visible.The underlying cause for the loosening is not clear.A patient related factor due to poor bone substance is likely.Based on investigation, the root cause was attributed to patient related issue.The event was most likely caused by the presence of poor bone substance which resulted in loosening of the implant and caused its failure.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 loose tibia.There is slight bone loss and cystic changes noted on ct scans.The physicians' plans to revise both the tibial and talar components.

• Brand Name: INFINITY ADAPTIS TIB SZ4LNG 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: 19629216
• Report Number: 3010667733-2024-00395
• Device Sequence Number: 8563392
• Product Code: HSN
• UDI-Device Identifier: 00889797069694
• UDI-Public: 00889797069694
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K181557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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: 33680014
• Device Lot Number: 1755575
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2023
• 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: Male