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

Model Number 22025410

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Damage to Ligament(s) (1952); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/16/2022

Event Type  Injury  

Event 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.

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.

Manufacturer Narrative

Please disregard the mfr report # 3010667733-2022-00127, 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 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
• 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: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 13776097
• MDR Text Key: 287258023
• Report Number: 3010667733-2022-00127
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889797075152
• UDI-Public: 00889797075152
• 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: 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
• Device Operator: Lay User/Patient
• Device Model Number: 22025410
• Device Catalogue Number: UNK_WWA
• Device Lot Number: 1662653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/16/2022
• Initial Date FDA Received: 03/15/2022
• Supplement Dates Manufacturer Received: 03/21/2022
• Supplement Dates FDA Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male