MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACET-E HIGHLY CROSSLINKED POLYETHYLENE; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091)

Event Date 06/09/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices - unicompartmental knee system tibial component precoat # 00584200502 lot # 62485585.Unicompartmental knee system femoral component high flex precoat # 00584201502 lot # 62482778.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-07168, 0001822565-2017-07272.It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent a right knee revision 7 months post initial knee surgery due to pain and swelling.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of revision operative notes.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are required.Per package insert, pain and swelling are some of the possible adverse effects of the pka procedure.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 paient underwent a right knee revision 19 months post initial knee surgery due to pain and swelling.Patient was revised to a total biomet knee.

• Brand Name: ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACET-E HIGHLY CROSSLINKED POLYETHYLENE
• Type of Device: PROSTHESIS, KNEE
• 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: 6963563
• MDR Text Key: 89799862
• Report Number: 0001822565-2017-07167
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK122529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 00584209510
• Device Lot Number: 62274428
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 109