MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY EVERLAST SZ 2+ 6MM TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 33683206

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Impaired Healing (2378); Blister (4537); Swelling/ Edema (4577)

Event Date 06/03/2021

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.H3 other text : device remains implanted in patient.

Event Description

It was reported that the patient underwent a total ankle replacement.Upon follow up visits post procedure the following was noted on (b)(6) 2021: mild blistering from swelling.No drainage or tunneling.On (b)(6) 2021: still has blistering.On (b)(6) 2021:wound healing.Some eschar in midportion.No tunneling.No drainage.On (b)(6) 2021: wet to dry dressing, start rom and possibly weight bearing.The patient had delayed healing of wound but superficial in nature.No signs of infection or deep tunneling.No drainage.Minimal swelling.On (b)(6) 2021: mild wound dehiscence with eschar, no evidence of deep infection or tunneling.On (b)(6) 2021: wound seems to be granulating very well.Smaller nature today from stand point as well as depth.No drainage, no signs of deep infection, no signs of superficial infection.Wound vac placed.Remain with wound care.On (b)(6) 2021: incision healing well.Granulating tissue.Wound much smaller, no tunneling, no signs of deep/superficial infection.On (b)(6) 2021: wound looks substantially better.Incisions healing well.Granulating tissue.Wound much smaller.No tunneling, no signs of deep infection.Minimal swelling.On (b)(6) 2021: wound totally healed.On (b)(6) 2021: wound totally healed but moderately swollen.On (b)(6) 2022: wound healed most of the way.1 small abrasion around anterior aspect of ankle but no tunneling and no deep wound.No drainage.Over the course of the adverse event, the patient received treatments like repeat wound check, non-weight bearing.Wound vac, wound care, compression, ice therapy and elevation.

Manufacturer Narrative

The complaint couldn't be confirmed, since the device was not returned for evaluation and no other evidences were provided, to confirm the reported delayed wound healing.Microbiologist reviewed the sterility of the dhr and noted: the subject device was packaged according to established design and process specifications, and got sterilized acording 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 Description

It was reported that the patient underwent a total ankle replacement.Upon follow up visits post procedure the following was noted on (b)(6) 2021: mild blistering from swelling.No drainage or tunneling.On (b)(6) 2021: still has blistering.On (b)(6) 2021:wound healing.Some eschar in midportion.No tunneling.No drainage.On (b)(6) 2021: wet to dry dressing, start rom and possibly weight bearing.The patient had delayed healing of wound but superficial in nature.No signs of infection or deep tunneling.No drainage.Minimal swelling.On (b)(6) 2021 and (b)(6) 2021: mild wound dehiscence with eschar, no evidence of deep infection or tunneling.On (b)(6) 2021: wound seems to be granulating very well.Smaller nature today from stand point as well as depth.No drainage, no signs of deep infection, no signs of superficial infection.Wound vac placed.Remain with wound care.On (b)(6) 2021: incision healing well.Granulating tissue.Wound much smaller, no tunneling, no signs of deep/superficial infection.On (b)(6) 2021: wound looks substantially better.Incisions healing well.Granulating tissue.Wound much smaller.No tunneling, no signs of deep infection.Minimal swelling.On (b)(6) 2021: wound totally healed.On(b)(6) 2021: wound totally healed but moderately swollen.On (b)(6) 2022: wound healed most of the way.1 small abrasion around anterior aspect of ankle but no tunneling and no deep wound.No drainage.Over the course of the adverse event, the patient received treatments like repeat wound check, non-weight bearing.Wound vac, wound care, compression, ice therapy and elevation.

• Brand Name: INFINITY EVERLAST SZ 2+ 6MM TOTAL ANKLE SYSTEM
• Type of Device: 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: 17980896
• MDR Text Key: 326241734
• Report Number: 3010667733-2023-00618
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889797074476
• UDI-Public: 00889797074476
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/17/2023

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 33683206
• Device Lot Number: 1687893
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 10/20/2023
• Supplement Dates Manufacturer Received: 11/20/2023
• Supplement Dates FDA Received: 12/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 123 KG