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); Bone Fracture(s) (1870); Inadequate Osseointegration (2646)
Date of Event	08/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.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 aseptic loosening of the tibia.The plan may involve switching to either an inbone or invision implant, depending on the condition of the talus and tibia.
Additional Manufacturer Narrative
The reported event that infinity adaptis tib sz4lng infinity adaptis was alleged of issue ¿implant loosening ¿ post-operatively¿ could not be confirmed, since the device was not returned for evaluation and no other evidence 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- there is a clear loosening and dislocation of the tibial component visible.Large cysts and some migration posterior including the dorsal cortex with an adjacent fracture.There are also large talar cysts suggesting loosening of the talar component as well.Overall, the bone substance looks poor.Whether a slight posterior positioning of the component and thus a surgery related cause has contributed to the loosening can only be assessed if there were some intra- or postoperative x-ray available.Based on the investigation the failure is most likely due to patient related issue i.E.Poor bone quality and slight posterior positioning of the component (a surgery related cause) has contributed to the loosening.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 aseptic loosening of the tibia.The plan may involve switching to either an inbone or invision implant, depending on the condition of the talus and tibia.

• 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: 20184932
• Report Number: 3010667733-2024-00577
• Device Sequence Number: 15686243
• Product Code: HSN
• UDI-Device Identifier: 00889797069694
• UDI-Public: 00889797069694
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/11/2024

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: 1749637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2023
• 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