MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC UNKNOWN PLATE: SIZE 3 RIGHT HT: 3 MM LEN:STANDARD; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_WWA

Device Problem Migration (4003)

Patient Problems Osteopenia/ Osteoporosis (2651); Malunion of Bone (4529)

Event Date 08/03/2022

Event Type  Injury  

Event Description

It was reported that there is a needed revision surgery for a tibia that needs to be adjusted out of the procurvatum and two more stems need to be added.In addition, talar plats need to be maximized given the subsidence.

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Disposition unknown.

Manufacturer Narrative

Please note corrections to the following: b1, b2, h1, h6 results and conclusion the reported event could be confirmed, since the need for a revision could be confirmed based on the received ct-scans.The complaint was forwarded to medical affairs for review with following result: "it was possible to assess the ct-scan for the latest revision planning and read the attached documents.In general, it shows severe osteoporosis with bone void and a coarse and open trabecular structure, indicating very poor bone quality.The tibial implant (inbone) shows radiolucency around it, indicating loosening.It is in procurvatum position.The polyethylene liner looks intact, although this cannot be assessed in detail on ct due to it being radiolucent.The talar component has subsided completely into the bone, leaving almost no remnant talus.It is definitively loose.With the information at hand, it is plausible that the revision is necessary for implant loosening, caused by poor bone quality, being a patient-related issue.Another reason for revision was already stated by the surgeon, being that the tibial component needs to be adjusted out of procurvatum.Without further clinical information, no other patient-related root causes can by assessed." a review of the device history was not possible because the lot number was not communicated.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.Based on the evaluation of the available information, the root cause was attributed to a patient related issue due to the poor bone quality.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that there is a needed revision surgery for a tibia that needs to be adjusted out of the procurvatum and two more stems need to be added.In addition, talar plats need to be maximized given the subsidence.

• Brand Name: UNKNOWN PLATE: SIZE 3 RIGHT HT: 3 MM LEN:STANDARD
• Type of Device: 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: 15316702
• MDR Text Key: 303247680
• Report Number: 0001043534-2022-00006
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/17/2022

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 Catalogue Number: UNK_WWA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2022
• Initial Date FDA Received: 08/29/2022
• Supplement Dates Manufacturer Received: 09/23/2022
• Supplement Dates FDA Received: 10/17/2022
• 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 Sex: Female