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

Catalog Number 00111214001

Device Problems Defective Component (2292); Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 02/26/2017

Event Type  Injury  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Once the investigation has been completed, a follow-up mdr will be submitted.Patient underwent a revision procedure.

Event Description

Notification date: feb 14, 2019 serious personal injuries.Patient¿s legal counsel reported patient underwent knee arthroplasty on (b)(6) 2017.Legal counsel further reports patient underwent a revision procedure on unknown date.Due to patient sustained serious personal injuries.No additional consequences have been reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Since the heraeus lot number is unknown, the heraeus dhr and zimmer biomet receiving inspection record cannot be retrieved.Since the heraeus dhr cannot be retrieved, the expiration and manufacture dates are unknown.Heraeus batch records review cannot be conducted since the heraeus lot number is unknown.Product examination was not performed as the product and product identification was not returned.This complaint is unconfirmed.Per heraeus, the root cause of the reported event and potential explanation as follows: a) bone cement viscosity insufficient intrusion depth of the bone cement into the bone spongiosa:loosening of the prosthesis, revision of the prosthesis.B) preparation/use of the device outside of the defined time frames application of the bone cement outside of the defined time frame: loosening of the prosthesis, revision of the prosthesis.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.H3 other text : device location unknown.

Event Description

No additional event information was received.

• Brand Name: PALACOS R 1X40 SINGLE
• Type of Device: BONE CEMENT
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8374923
• MDR Text Key: 137292826
• Report Number: 0001526350-2019-00130
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/26/2019

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 Catalogue Number: 00111214001
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/14/2019
• Initial Date FDA Received: 02/27/2019
• Supplement Dates Manufacturer Received: 08/23/2019
• Supplement Dates FDA Received: 08/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention