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

Model Number 22025412

Device Problems Appropriate Term/Code Not Available (3191); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Rheumatoid Arthritis (1724); Loss of Range of Motion (2032); Implant Pain (4561); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/16/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient underwent a left ankle hardware removal and left revision total ankle replacement with possible collateral ligament repair with internal brace and left achilles tendon lengthening all on the left.The patient is status post left ankle replacement 2019 but continues to develop arthritis changes particular along the medial and lateral gutter along with pain and reduced range of motion.The patient also has some loosening of implant on imaging.The patient elected for revision replacement with larger implant and is scheduled for surgery (b)(6) 2021.The reports overall he is doing ok.He remains followed with rheumatology for his ra which has been well controlled on xeljanz.

Manufacturer Narrative

Correction: d1, d4, h6 codes.Please disregard the mfr report, 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 left ankle hardware removal and left revision total ankle replacement with possible collateral ligament repair with internal brace and left achilles tendon lengthening all on the left.The patient is status post left ankle replacement 2019 but continues to develop arthritis changes particular along the medial and lateral gutter along with pain and reduced range of motion.The patient also has some loosening of implant on imaging.The patient elected for revision replacement with larger implant and is scheduled for surgery (b)(6) 2021.The reports overall he is doing ok.He remains followed with rheumatology for his ra which has been well controlled on xeljanz.

• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13771620
• MDR Text Key: 288477536
• Report Number: 3010667733-2022-00121
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889797075169
• UDI-Public: 00889797075169
• 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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 22025412
• Device Catalogue Number: 22025412
• Device Lot Number: UNKNOWN
• 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: 03/26/2022
• 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): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male