MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC ORTHOLOC 3DI PLATING SYSTEM; PLATE, FIXATION, BONE

Model Number 58813516

Device Problems Break (1069); Fracture (1260)

Patient Problems Failure of Implant (1924); Inadequate Osseointegration (2646); Metal Related Pathology (4530)

Event Date 06/20/2022

Event Type  Injury  

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.Should additional information become available, it will be provided on a supplemental report.Device remains implanted in patient.

Event Description

It was reported that the talar components are loose.Has caused significant metallosis in surrounding tissues.At least one of the screws through the plate broke too.Will have to undergo another surgery.

Event Description

It was reported that the talar components are loose.Has caused significant metallosis in surrounding tissues.At least one of the screws through the plate broke too.Will have to undergo another surgery.

Manufacturer Narrative

Correction h6 results code, conclusion code.The reported event could be confirmed since images of ct scans were provided and matches the alleged failure mode.There are many clinical factors that can affect the results of any surgery, such as surgical technique, pre-operative and post-operative care, the implant, patient pathology and daily activity.A medical professional reviewed the received information and noted the following: ¿the breakage of a screw was reliably assessed on the mpr of the ct-scan.Poor bone quality and incomplete subtalar fusion led to loosening and subsidence of the talar component and unavoidable breakage of a screw.Multiple interventions reflecting the initial complex hindfoot pathology relate to the bone quality.¿ based on investigation, the root cause was attributed to a patient factor related issue.As noted by a medical professional, the failure was caused by poor bone quality and incomplete subtalar fusion.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: ORTHOLOC 3DI PLATING SYSTEM
• Type of Device: PLATE, FIXATION, BONE
• 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: 15041492
• MDR Text Key: 296058427
• Report Number: 3010667733-2022-00247
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00840420113917
• UDI-Public: 00840420113917
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K120359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/23/2022

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: 58813516
• Device Catalogue Number: 58813516
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2022
• Initial Date FDA Received: 07/18/2022
• Supplement Dates Manufacturer Received: 08/29/2022
• Supplement Dates FDA Received: 09/24/2022
• 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; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female