MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL COMPONENT PRECOAT SIZE 4; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2021-02301, 0001822565-2021-02303, 0002648920-2021-00223, 0002648920-2021-00224, 0002648920-2021-00225.Medical product femoral component size e left item# 00588001501 lot# 62958321; articular surface with hinge post item# 00588005012 lot# 63256586; all poly patella standard size 32 mm diameter 8.5 mm thickness item# 00597206532 lot# 63382530; stem extension straight 11mm dia x 100mm length item# 00598801011 lot# 62893869; stem extension straight long 14mm dia x 155mm length item# 00598801114 lot# 37214059.Report source- (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient was revised approximately four years and ten months¿ post implantation due to unknown reasons.Attempts to obtain additional information have been made; however, no more information is available at this time.
Event or Problem Description
Upon reassessment of the reported event, this device was determined to not be reportable as it was not involved in the event.The initial report was submitted in error and should be voided.
Additional Manufacturer Narrative
Upon reassessment of the reported event, this device was determined to not be reportable as it was not involved in the event.The initial report was submitted in error and should be voided.

• Brand Name: TIBIAL COMPONENT PRECOAT SIZE 4
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12348777
• Report Number: 0001822565-2021-02302
• Device Sequence Number: 13764243
• Product Code: KRO
• UDI-Device Identifier: 00889024199026
• UDI-Public: (01)00889024199026(17)201031(10)63185060
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K013385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2021

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: 10/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00588000400
• Device Lot Number: 63185060
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 09/28/2021
• 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