MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN 11X190MM CEMENTED STEM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 12/15/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: item 00585004201 lot 64178822; item 00585002014 lot 63955585; item 00585001296 lot 64535490.Foreign (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as 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 filed for this event, please see associated reports: 0001822565-2021-00073.

Event Description

Is was reported that the patient underwent a knee revision procedure of the femoral components due to disassociation of the distal femoral component from the stem.Attempt have been made but no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d1, g3, g6, h1, h2, h10.

Event Description

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

Event Description

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

Manufacturer Narrative

No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The dhr was unable to be performed as the lot number of the device involved in the event is unknown.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient had in situ a zss.Patient needed revision surgery as distal femoral component detached from stem; patient has 2 previous revision surgeries due to femoral component loosening with anterolateral perforation of the femur during the second revision.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: UNKNOWN 11X190MM CEMENTED STEM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11130970
• MDR Text Key: 225502065
• Report Number: 0001822565-2021-00074
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2021

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 Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 01/07/2021
• Supplement Dates Manufacturer Received: 02/24/2021; 06/08/2021
• Supplement Dates FDA Received: 03/01/2021; 06/15/2021
• 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