MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CEMENT SHIELD HINGE SERVICE KIT SIZE B; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 00585002012 - articular surface - 63530803.00585204035 - stem collar - 64073497.00585001296 - polyethylene insert - 64058793.00597206529 - all poly patella - 64163932.00585004202 - femoral component - 63917928.00585205015 - fluted stem extension - 64069897.00545001731 - femoral diaphyseal cone - 63768449.00598304027 - screw - 64057985.00588000302 - tibial component - 63548490.00545001341 - tibial cone - 64204230.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported patient underwent a zss revision procedure for unknown reasons.During the revision the service parts were removed.Due to the wrong parts in the box the old service parts were put back into patient.Attempts have been made and no further information has been provided.
Event or Problem Description
The patient was revised due to the patella tracking laterally.It was noted the position of the femur was changed, as well as tissue debridement.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a1; b4; b5; g4; g7; h1; h2.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: 0002648920 - 2020 - 00529.
Event or Problem Description
Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.
Additional Manufacturer Narrative
Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.

• Brand Name: CEMENT SHIELD HINGE SERVICE KIT SIZE B
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10941760
• Report Number: 0001822565-2020-03992
• Device Sequence Number: 791531
• Product Code: KRO
• UDI-Device Identifier: 00889024196339
• UDI-Public: (01)00889024196339(17)220630(10)62739301
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K070978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 00585007512
• Device Lot Number: 62739301
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 12/04/2020; 02/15/2021
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 12/15/2020; 02/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention