MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRABECULAR METAL TOTAL ANKLE TIBIAL BASE COMPONENT; PROSTHESIS, ANKLE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Ossification (1428); Pain (1994); Loss of Range of Motion (2032); Swelling (2091)

Event Date 12/23/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: mfr#0001822565-2018-01785 and mfr#0001822565-2018-01786 concomitant products: trabecular metal total ankle talar component pn00830002400 ln62990953, trabecular metal total ankle tibial insert pn00830005400 ln62861441.(b)(6) this product is manufactured by zimmer biomet (b)(4) and is cleared for export only, not for distribution in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states under 510k number k120906.Reported event was confirmed by review of the provided x-rays and op notes.Per the op report, patient had some anterior cartilage damage, increased pain, and a cyst.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that the patient underwent an initial right ankle replacement.Subsequently, the patient suffered from recurring heterotopic ossification one year later.The patient underwent debridement and requires repeat radioablation.It was also reported the patient suffers from pain, moderate swelling/stiffness, tight laxity, gait abnomality and restriction of hindfoot motion.No plans have been made for revision at this time.

• Brand Name: TRABECULAR METAL TOTAL ANKLE TIBIAL BASE COMPONENT
• Type of Device: PROSTHESIS, ANKLE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7399015
• MDR Text Key: 104451426
• Report Number: 0001822565-2018-01784
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PNA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00830004400
• Device Lot Number: 63046939
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2015
• 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
• Patient Age: 73 YR
• Patient Weight: 77