MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL COMPONENT SIZE E LEFT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Joint Laxity (4526); 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: 0001822565-2021-02302, 0001822565-2021-02303, 0002648920-2021-00223, 0002648920-2021-00224, 0002648920-2021-00225.Medical product tibial component precoat size 4 item# 00588000400 lot# 63185060; 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
It was reported that a patient was revised approximately four years and ten months¿ post implantation due to instability.Attempts to obtain additional information have been made; however, no more information is available.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b1, b4, b5, g3, g6, h1, h2, h6, and h10.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b4, b5, g3, g6, h1, h2, h3, h6, and h10.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Attempts to obtain additional information have been made; however, no more information is available.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot be determined.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: FEMORAL COMPONENT SIZE E LEFT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12348756
• Report Number: 0001822565-2021-02301
• Device Sequence Number: 13764242
• Product Code: KRO
• UDI-Device Identifier: 00889024199149
• UDI-Public: (01)00889024199149(17)200531(10)62958321
• 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,Followup
• Report Date (Section B): 10/14/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00588001501
• Device Lot Number: 62958321
• 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; 10/11/2021
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 09/28/2021; 10/14/2021
• 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