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	Neuropathy (1983); Loss of Range of Motion (2032); Numbness (2415); Swelling/ Edema (4577)
Date of Event	05/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "adaptis subject (b)(6) patient presented to clinic on (b)(6) 2022 (5 weeks and 5 days s/p left tar procedure), c/o plantar numbness and difficulty with toe flexion.Upon exam, the surgeon confirmed superficial and peroneal nerves are intact.Sural nerve is intact.The surgeon ordered an emg; on (b)(6) 2022 emg report/clinical impression: patient has compressive neuropathy at left tarsal tunnel and fibular head, due to postop swelling, casting, and the boot.F/u pending.Update 07 mar 2023: patient continues to have tibial nerve irritation.The surgeon does not believe this event is due to a traumatic tibial nerve laceration during tar procedure, but residual irritation from the nerve block or swelling.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "adaptis subject (b)(6) patient presented to clinic on (b)(6) 2022 (5 weeks and 5 days s/p left tar procedure), c/o plantar numbness and difficulty with toe flexion.Upon exam, the surgeon confirmed superficial and peroneal nerves are intact.Sural nerve is intact.The surgeon ordered an emg; (b)(6) 2022 emg report/clinical impression: patient has compressive neuropathy at left tarsal tunnel and fibular head, due to postop swelling, casting, and the boot.F/u pending.Update (b)(6) 2023: patient continues to have tibial nerve irritation.The surgeon does not believe this event is due to a traumatic tibial nerve laceration during tar procedure, but residual irritation from the nerve block or swelling.".
Additional Manufacturer Narrative
The complaint couldn't be confirmed, since the device was not returned for evaluation and no other evidence were provided.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.

• 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.; 11576 memphis arlington rd; arlington TN 38002
• 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: 20307762
• Report Number: 3010667733-2024-00643
• Device Sequence Number: 7792176
• Product Code: HSN
• UDI-Device Identifier: 00889797073080
• UDI-Public: 00889797073080
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2024

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: 33680034
• Device Lot Number: 1723169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2022
• 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 Age: 56 YR
• Patient Sex: Male
• Patient Weight: 73 KG