MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INTEGRA DEVICE; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	200222905
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Damage to Ligament(s) (1952); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision surgery to remove the hardware and to perform a tendon lengthening of the midfoot; rearfoot or ankle ankle-total ankle arthroplasty; ankle-reconstruction of ankle ligament with graft.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Additional Manufacturer Narrative
Please disregard the mfr report # 3010667733-2022-00126, as per further received information, the device information confirmed that the reported event is related to an integra product, not a stryker trauma product.
Event or Problem Description
It was reported that the patient underwent a revision surgery to remove the hardware and to perform a tendon lengthening of the midfoot; rearfoot or ankle ankle-total ankle arthroplasty; ankle-reconstruction of ankle ligament with graft.

• Brand Name: INTEGRA DEVICE
• 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: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 13776085
• Report Number: 3010667733-2022-00126
• Device Sequence Number: 3733725
• Product Code: HSN
• UDI-Device Identifier: 00840420124111
• UDI-Public: 00840420124111
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2022

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 Model Number: 200222905
• Device Catalogue Number: UNK_WWA
• Device Lot Number: 1684593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male