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

Model Number 200012902

Device Problems Break (1069); Disassembly (1168)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/06/2017

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation; however films were supplied for review.Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.Associated with reports 1043534-2017-00025 and 1043534-2017-00026.

Event Description

Allegedly, it was reported that the patient underwent an ankle surgical procedure.Approximately 8 months post-op, it was found that the tibial stem implants are disassociated or broken.No additional information is available at this time.

Manufacturer Narrative

The parts were returned.The top and mid stem were returned seated together and the base stem was returned separate.Visual inspection shows no overall gross deformation.There was no damage to the female threads of the base stem or the male thread of the mid stem.Also, review of the mid stem threading did not show any deformation or obstruction that would prevent the base stem from seating properly.The base stem was able to be seated on the mid stem without any issues.Radiographic images were provided and show the base stem separated from the mid stem.

• Brand Name: INBONE®
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; 38002
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; 38002
• Manufacturer Contact: timothy nickel ; 1023 cherry road; 901451-631
• MDR Report Key: 6368320
• MDR Text Key: 69016608
• Report Number: 1043534-2017-00024
• Device Sequence Number: 1
• Product Code: HSA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/01/2022
• Device Model Number: 200012902
• Device Lot Number: 1538367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/06/2017
• Event Location: Other
• Date Manufacturer Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 46 YR