MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC FLAT CUT TALAR DOME SZ 4 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33680034
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nerve Damage (1979); Loss of Range of Motion (2032); Post Operative Wound Infection (2446)
Date of Event	03/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for evaluation as it remains implanted in the patient therefore an evaluation of the device cannot be performed.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 revision surgery due to an infection.The wound reportedly developed in late february or early march.Notably, foot drop related to a preoperative nerve block was identified as a remarkable circumstance in this event.A revision surgery is planned for mid to late april.
Additional Manufacturer Narrative
Correction to d4 (gtin).The complaint could be confirmed, since the information for evaluation matches the alleged failure, as only a cement spacer is visible which does confirm revision.Upon further investigation of the ct scans by healthcare professionals the following was observed: the ct scan shows a girdlestone situation at the site of the former tar.The provided clinical information gives infection as the underlying cause of the revision.The implantation took place in (b)(6) 2024, while the symptoms started in (b)(6) 2025 and the explantation is planned for end of (b)(6) (which does not make sense as the ct scan is showing, that the tar has been explanted already).It is possible, that the two-staged revision with implantation of the new tar is going to be completed on the (b)(6).However, the time between implantation and infection is around six months, which means an intermediate time span between the two events.An implantation related infection (due to the procedure) is possible but cannot be confirmed with the given information here.Sterility assurance reviewed sterility documents and noted: the subject device was packaged according to established design and process specifications and got sterilized according to process.No deviation for a non-conformance could be found.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.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The digital stryker prophecy team received a ct scan indicating that the patient may require revision surgery due to an infection.The wound reportedly developed in late (b)(6) or early (b)(6).Notably, foot drop related to a preoperative nerve block was identified as a remarkable circumstance in this event.A revision surgery is planned for mid to late (b)(6).

• Brand Name: FLAT CUT TALAR DOME SZ 4 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21852177
• Report Number: 3010667733-2025-00467
• Device Sequence Number: 15479083
• Product Code: HSN
• UDI-Device Identifier: 00889797073080
• UDI-Public: (01)00889797073080(11)240729(17)320729(10)1791782
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2025

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: 33680034
• Device Lot Number: 1791782
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 04/16/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2024
• 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: Unknown