MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER TIBIAL COMPONENT PRECOAT; PROSTHESIS KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling (2091); No Code Available (3191)

Event Date 08/11/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: articular surface catalog # 00584202209, lot # 62849181, femoral component catalog # 00584201302, lot# 62543939.Customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001822565 - 2018 - 00946, 1822565-2016-00090.Product location is unknown.

Event Description

It was reported that the patient had initial right knee arthroplasty.The patient was experiencing pain, swelling, limited range of motion, balance issues with restrictions on activities post implantation.

Manufacturer Narrative

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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history determined that no further action is required as no trends were identified.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.Root cause was unable to be determined.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.

• Brand Name: ZIMMER TIBIAL COMPONENT PRECOAT
• 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: 7275701
• MDR Text Key: 100231705
• Report Number: 0001822565-2018-00945
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK033363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00584200202
• Device Lot Number: 62850859
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2018
• Initial Date FDA Received: 02/15/2018
• Supplement Dates Manufacturer Received: 02/19/2018; 03/26/2018
• Supplement Dates FDA Received: 02/24/2018; 03/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2014
• 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: 46 YR
• Patient Weight: 57