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

Model Number	33680034
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Rheumatoid Arthritis (1724); Loss of Range of Motion (2032); Implant Pain (4561); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem 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.
Additional Manufacturer Narrative
Please disregard the mfr report # 3010667733-2022-00124, 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 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 on (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
• 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: 13776076
• Report Number: 3010667733-2022-00124
• Device Sequence Number: 3707563
• Product Code: HSN
• UDI-Device Identifier: 00889797073080
• UDI-Public: 00889797073080
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K191393
• 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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 33680034
• Device Catalogue Number: 33680034
• Device Lot Number: UNKNOWN
• 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: 03/26/2022
• 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: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male