MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TIB SZ3LNG INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33680013
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Erythema (1840)
Date of Event	04/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "subject: (b)(6) - infinity¿ with adaptis¿ total ankle replacement follow-up (itar2).(b)(6) 2021: worsening redness around incision.Delayed wound healing.No evidence of deep infection, hold motion, continue soap and water wash, bactrim antibiotic prescribed.(b)(6) 2021: worsening.Small area of wound dehiscence with mild exudate mild erythema.No purulent drainage, no signs of deep infection.Continue wet-to-dry dressings over small area of wound dehiscence.(b)(6) 2021: no change.Wound debrided in office.Hold motion for another week.(b)(6) 2021: improving.Wound appears less irritated, continue wet-to-dry dressings, referral to wound care.(b)(6) 2021: improving.Granulation tissue bed looks exceptional.Wound appears to be responding excellent.Bactrim to be cautious.(b)(6) 2021: improving.Incision healing.Mild wound dehiscence.Much improved.Continuw with wound care.(b)(6) 2021: improving.Incision healing well.Much improved.(b)(6) 2021: resolved.Incision healed.No drainage.No signs of infection.".
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.
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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
As reported: "subject: (b)(6) - infinity¿ with adaptis¿ total ankle replacement follow-up (itar2).(b)(6) 2021: worsening redness around incision.Delayed wound healing.No evidence of deep infection, hold motion, continue soap and water wash, bactrim antibiotic prescribed.(b)(6) 2021: worsening.Small area of wound dehiscence with mild exudate mild erythema.No purulent drainage, no signs of deep infection.Continue wet-to-dry dressings over small area of wound dehiscence.(b)(6) 2021: no change.Wound debrided in office.Hold motion for another week.(b)(6) 2021: improving.Wound appears less irritated, continue wet-to-dry dressings, referral to wound care.(b)(6) 2021: improving.Granulation tissue bed looks exceptional.Wound appears to be responding excellent.Bactrim to be cautious.(b)(6) 2021: improving.Incision healing.Mild wound dehiscence.Much improved.Continue with wound care.(b)(6) 2021: improving.Incision healing well.Much improved.(b)(6) 2021: resolved.Incision healed.No drainage.No signs of infection.".

• Brand Name: INFINITY ADAPTIS TIB SZ3LNG 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; 1023 cherry rd; memphis TN 38117
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21468385
• Report Number: 3010667733-2025-00202
• Device Sequence Number: 3391333
• Product Code: HSN
• UDI-Device Identifier: 00889797069687
• UDI-Public: 00889797069687
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

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: 33680013
• Device Lot Number: 1690622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2020
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 65 KG