MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL TIBIAL CEMENTED SIZE E LEFT MEDIAL; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	05/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2022-01271, 0001825034-2022-01273.Partial articular surface left medial size e 9 mm thickness item# 42518200509 lot# 64660723 partial femur cemented size 4 left medial item# 42558000401 lot# 64903213 (b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.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 due to pain after a fall.There is no additional information available.
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.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.Per package insert 01-50-1264, pain is known adverse effect of the system.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: PARTIAL TIBIAL CEMENTED SIZE E LEFT MEDIAL
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14470399
• Report Number: 0001825034-2022-01272
• Device Sequence Number: 4904351
• Product Code: HSX
• UDI-Device Identifier: 00880304812680
• UDI-Public: (01)00880304812680(17)310306(10)64756083
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2022

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 Model Number: N/A
• Device Catalogue Number: 42538000501
• Device Lot Number: 64756083
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Patient Sex: Female
• Patient Weight: 100 KG