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

Model Number	200009901
Medical Device Problem Codes	Osseointegration Problem (3003); Migration (4003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Implant Pain (4561)
Date of Event	01/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for evaluation as it remains implanted in the patient.A review of the device history is not possible because the lot number was not communicated.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 total ankle replacement.Allegedly, the patient may need to undergo a revision surgery due to pain and loosening of the tibia stem of the prosthesis.No operating has been done.The patient has been going through physical therapy with no positive returns.
Additional Manufacturer Narrative
Correction - h6 (device code, results and conclusion code) the reported event could not be confirmed, based on available medical records and experts opinions.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.Formal medical opinion was sought from an experienced independent medical expert and he opined below: ¿the ct-scan shows that all the components of the device are intact (tibial tray, stem, pe liner and talar component).No disassembly from any component.Status after 2 suture fixation of the syndesmosis, small metal anchor plates still present, not interfering with the tar.Status after osteosynthesis of the distal tibia, hardware removed, no fracture at this moment.There is radiolucency around the tibial component stem proximally, width less than 2 mm.Tibia tray and distal parts of the stem fixed well to the bone.Talar component well-fixed.¿ based on available information, the conclusions is most likely patient-related (bone quality).Based on investigation, the root cause was attributed to a patient related issue.The failure was caused by poor bone quality.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
It was reported that the patient underwent a total ankle replacement.Allegedly, the patient may need to undergo a revision surgery due to pain and loosening of the tibia stem of the prosthesis.No operating has been done.The patient has been going through physical therapy with no positive returns.

• Brand Name: INBONE STEM, TIBIAL, BASE SIZE, 16 MM, RIGHT & 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: 16522441
• Report Number: 3010667733-2023-00105
• Device Sequence Number: 2393531
• Product Code: HSN
• UDI-Device Identifier: 00840420123831
• UDI-Public: 00840420123831
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K051023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: 200009901
• Device Catalogue Number: 200009901
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 06/07/2023
• 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: Other
• Patient Sex: Female