MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA CONSTRAINED POSTERIOR STABILIZED (CPS) ARTICULAR SURFACE LEFT 10MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: unknown persona femoral component catalog #: ni, lot #: ni, unknown persona tibial component catalog #: ni ,lot #: ni.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the patient retained the implant.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Investigation incomplete.
Event or Problem Description
It was reported that the patient underwent a knee arthroplasty revision of the articular surface to increase the patient's stability.Attempts have been made, however, no additional information is available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h10.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: PERSONA CONSTRAINED POSTERIOR STABILIZED (CPS) ARTICULAR SURFACE LEFT 10MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12569721
• Report Number: 0001822565-2021-02861
• Device Sequence Number: 16961307
• Product Code: MBH
• UDI-Device Identifier: 00889024238206
• UDI-Public: (01)00889024238206(17)220430(10)63644351
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K123459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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: 04/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 42512600910
• Device Lot Number: 63644351
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 10/21/2021
• 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 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention