MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL ARTICULAR SURFACE 10 MM SERIES 4; KNEE, PROSTHESIS

Catalog Number 00578807010

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 08/18/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 1822565-2014-01184.(b)(4).Complaint sample was evaluated and the reported event was confirmed.Op notes provided for left knee revision.It was apparent the locking ring component was broken into two pieces and articular surface was loose, hence revision surgery carried out.During placement the tibial component was inserted carefully and impacted, excess cement was removed especially posteriorly.A trial spacer was inserted and knee placed ~ 30 degrees of flexion until hardened.12 mm polyethylene liner was inserted and impacted.Excellent stability was achieved mediolateral, equal flexion and extension gaps.There were no complications.X-ray assessment performed and it shows left knee x-rays dated (b)(6) 2014 demonstrate a miller galante medial unicompartmental knee arthroplasty with polyethylene liner wear versus disruption.Review of the complaint history determined that no further action is required as no trends were identified.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 is reported that the patient underwent an articular surface exchange.During this surgery, it was discovered that the locking mechanism of the tibial component was broken.

• Brand Name: TIBIAL ARTICULAR SURFACE 10 MM SERIES 4
• 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: 6888532
• MDR Text Key: 87181614
• Report Number: 0001822565-2017-06622
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK942263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2010
• Device Catalogue Number: 00578807010
• Device Lot Number: 69512700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2000
• 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; Required Intervention
• Patient Age: 45 YR
• Patient Weight: 87