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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Impaired Healing (2378); Blister (4537); Swelling/ Edema (4577)
Date of Event	06/03/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17980896
• Report Number: 3010667733-2023-00618
• Device Sequence Number: 14076409
• Product Code: HSN
• UDI-Device Identifier: 00889797074476
• UDI-Public: 00889797074476
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K193067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 33683206
• Device Lot Number: 1687893
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 12/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2020
• 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: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 123 KG