MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM ANKLE TALAR 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 01/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00830004300, tm ankle tibial base component, 77002854, 00235701808, periarticular locking plate fibula, 62745572, 00830005300, tibial insert component, 62637225.Report source, foreign - the event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 01359, 0001822565 - 2018 - 01361.Remains implanted.

Event Description

It was reported that the patient underwent an initial ankle procedure.Subsequently, the patient underwent observation for heterotopic ossification treatment.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

Reported event was confirmed by review of x-rays provided.X-ray reviewer stated subtalar and midfoot fusion.Bony fusion is noted along the medial and lateral ankle secondary to heterotopic ossification.Mild bimalleolar ankle soft tissue swelling.Osteopenia.Dhr was reviewed and no discrepancies were found.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 patient underwent initial ankle procedure approximately four years prior.Subsequently, patient underwent observation for heterotopic ossification treatment.It was also reported the patient suffers from pain, swelling, and limited range of motion.

• Brand Name: TM ANKLE TALAR COMPONENT
• Type of Device: PROSTHESIS, ANKLE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7322185
• MDR Text Key: 101830897
• Report Number: 0001822565-2018-01360
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: PK120906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• 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: 00830001300
• Device Lot Number: 62416036N
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 69 YR
• Patient Weight: 95