MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM ANKLE XL POLY INSERTS; KNEE PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Ossification (1428); Pain (1994); Swelling (2091); Limited Mobility Of The Implanted Joint (2671)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).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 XL POLY INSERTS
• Type of Device: KNEE PROSTHESIS
• 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: 7544044
• MDR Text Key: 109228518
• Report Number: 0001822565-2018-02870
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK120906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/24/2018

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: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 00830005300
• Device Lot Number: 62637225
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 05/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 95