MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER TRABECULAR METAL TOTAL ANKLE TALAS; ANKLE PROSTHESIS

Catalog Number 0083002200

Device Problems Unstable (1667); Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Joint Dislocation (2374); No Code Available (3191)

Event Date 10/05/2015

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It was reported that the patient has increased displacement of talus on the tibia.

Manufacturer Narrative

Review of the device history records for the talus did not find any deviations or anomalies.The devices were used for treatment.No other complaints of any type have been reported for this lot of (b)(4).The provided operative notes indicate to correct a deformity that an osteotomy of the medial malleolus was performed.The notes also states that the joint was "appropriately balanced" prior to closure.The provided part numbers are a combination that has been approved for use and is a legally-marketed combination.With the provided information an exact cause could not be determined.The investigation could not verify or identify any evidence of product contribution to the reported problem.Based on the available information, the need for corrective action is not indicated.

Manufacturer Narrative

This report is being amended to reflect changes in sections.This report will be amended when our investigation is complete.

Event Description

It is reported the patient underwent arthroscopy and debridement due to subluxation.No products were revised.

Manufacturer Narrative

No devices were explanted therefore a determination on the condition of the components could not be made.It is noted in revision op-otes that "inspection of the total ankle arthroplasty confirmed the sublaxation was present.Using a shaver, a curette, and a lightening burr, we were able to remove the impinging bone between the medial side of the talus and the medial malleolus as well as the scar in this area.We were able to get the ankle back in a more neutral position." complaint history search revealed no additional complaints against the related part and lot combination.X-rays were reviewed by outside surgeon and stated, "the gap in the medial malleolus reduction in the immediate postop x-ray is outside of the norm.The talar component size appears appropriate.The talar component does not appear to show abnormal or incomplete impaction." a definitive root cause remains undetermined with the information provided.

Manufacturer Narrative

The following report is being submitted to relay additional information received the additional information received does not change any previously reported investigation results.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that patient underwent a surgery to correct instability, subluxation and removal of impinging bone nine (9) months post implantation.

Manufacturer Narrative

The following report is being submitted to relay additional information received the complaint is confirmed based on the medical operative records provided.The investigation does not change any previously reported findings.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional information is available to report at this time.

• Brand Name: ZIMMER TRABECULAR METAL TOTAL ANKLE TALAS
• Type of Device: ANKLE PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; po box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; 345 e. main st.; warsaw, IN 46580 ; 8006133161
• MDR Report Key: 4994691
• MDR Text Key: 22861096
• Report Number: 1822565-2015-01435
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup,Followup,Followup,Followup,Followup
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 0083002200
• Device Lot Number: 62290840N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 64