MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE STEM, TIBIAL, BASE SIZE, 16 MM, RIGHT AND LEFT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	200009901
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that during a primary implant procedure the surgeon could not get the morse taper to seat with these 2 implants.They proceeded to remove the tibial tray and stems, then tried to seat the morse taper on the back table which did not work either.After several tries and 90 minute delay, the surgeon opened new implants and the morse taper seated fine.They had to remove and open different implant.They replaced with another 16mm base stem, different lot number and it worked fine.
Additional Manufacturer Narrative
The complaint could not be confirmed, indeed the product was returned for evaluation, but it does not matches the alleged failure.The device inspection revealed the following: visual examination of the received products shows that they got received in assembled conditions, the two parts are not completely aligned with each other.Furthermore, the parts received are in an used but good condition.Engineering reviewed the received information and noted: from further examination of the part i received, it looks fine.1) no damage to threads from misalignment or an incorrect connection.2) the base stem is as it should be from a design perspective; seated correctly (i.E., flush, no gaps).3) tibial tray looks to be interfaced correctly with the base stem also.Note: i did try to disconnect the tibial tray from the base stem, but it is really secured in there.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that during a primary implant procedure the surgeon could not get the morse taper to seat with these 2 implants.They proceeded to remove the tibial tray and stems, then tried to seat the morse taper on the back table which did not work either.After several tries and 90 minute delay, the surgeon opened new implants and the morse taper seated fine.They had to remove and open different implant.They replaced with another 16mm base stem, different lot number and it worked fine.

• Brand Name: INBONE STEM, TIBIAL, BASE SIZE, 16 MM, RIGHT AND LEFT
• 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: 17760943
• Report Number: 3010667733-2023-00540
• Device Sequence Number: 12454521
• Product Code: HSN
• UDI-Device Identifier: 00840420123831
• UDI-Public: 00840420123831
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K051023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 200009901
• Device Lot Number: 1748185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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
• Patient Sex: Unknown