MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY EVERLAST SZ 4 6MM TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	33684406
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Inflammation (1932)
Date of Event	05/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint couldn't be confirmed, since the device was not returned for evaluation and no other evidences were provided.A review of the device history was not possible because the lot number provided is unknown in our systems.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.A review of the sterility documents was not possible, as the lot number 167705 provided is unknown in our systems.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
As reported: "subject: (b)(6) infinity¿ with adaptis¿ total ankle replacement follow-up (itar2).(b)(6) 2022: wound dehiscence.Delayed wound healing.Small area of wound dehiscence noted in the flap area of the incision at the 3 week post op visit.Recommendations included xeroform dry dressing changes daily, wash with soap and water, continue nonweight bearing, and follow-up in 1 week.(b)(6) 2022: improving.Incision is healing well.1 small area of eschar.Follow-up 2-3 weeks.(b)(6) 2022: worsening.Redness around incision site with new drainage.Recommend irrigation and debridement with iv antibiotics and revision with poly exchange.Everlast poly was removed and discarded.(b)(6) 2022: improving.(b)(6) 2022: improving.Incision healing well.Medihoney and gauze dressing.Daily dressing changes.Okay to wash with soap and water.Nonweight bearing.Home pt, very gentle ankle range of motion.(b)(6) 2022: improving.Incision healing well.Incision has almost fully healed, just 1 pinpoint area that he can continue medihoney and gauze in the next few days until this heals up.Gradual progression to full weightbearing in the tall boot.Commence physical therapy.(b)(6) 2022: improving.Incision healing well.Continue with cushioned athletic shoe.Finish out physical therapy.Revision surgery with poyethylene exchange on (b)(6) 2022.".

• Brand Name: INFINITY EVERLAST SZ 4 6MM TOTAL ANKLE SYSTEM
• Common Device Name: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 20426069
• Report Number: 3010667733-2024-00717
• Device Sequence Number: 18039668
• Product Code: HSN
• UDI-Device Identifier: 00889797074599
• UDI-Public: 00889797074599
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/11/2024

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: 33684406
• Device Lot Number: 167705
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 86 KG