MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PALACOS R 1X40 SINGLE; BONE CEMENT

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 09/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2019-00741, 0001822565-2019-04404, 0001822565-2019-04405, 3007963827-2019-00290, and 0002648920-2019-00742.Concomitant medical products: all poly patella size 35 mm dia.Standard 9.0 mm thickness catalog#: 00597206535 lot#: 63868921, articular surface anterior constrained size blue catalog#: 00597605012 lot#: 63950858, femoral component precoat size g right catalog#: 00595001702 lot#: 63958991, stemmed tibial component precoat size 7 catalog#: 00598005701 lot#: 64155865.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent a total knee arthroplasty.Subsequently, the patient started having fluid on the knee.Around eleven months after the initial procedure, the patient was revised due to infection.All products were removed and replaced with antibiotic cement spacers.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record 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.

• Brand Name: PALACOS R 1X40 SINGLE
• Type of Device: BONE CEMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9185821
• MDR Text Key: 162434037
• Report Number: 0001822565-2019-04404
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2020

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: 00111214001
• Device Lot Number: 89664767
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 10/14/2019
• Supplement Dates Manufacturer Received: 03/05/2020
• Supplement Dates FDA Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 104