MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA ARTICULAR SURFACE FIXED BEARING CONSTRAINED CONDYLAR KNEE (CCK); PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	09/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: lnvatec osc 13x90x1.27f catalog # 13-0901-27l-f1 lot # 365942; 3.5mm hex head screw x38mm catalog # 20-8000-000-18 lot # unknown; tm tibial central cone sz xsm catalog # 42-5450-005-10 lot # 64751284; psn rev tib fix np sz f r catalog # 42-5420-075-02 lot # 64835311; psn rev 6mm off stem 12x135 catalog # 42-5606-135-12 lot # 65085732; psn tib hlf blk sz ef rm 10mm catalog # 42-5558-054-10 lot # 64729055; psn tib hlf blk sz ef rl 10mm catalog # 42-5558-052-10 lot # 64729050; psn rev fem cmt ccr std sz 9r catalog # 42-5046-066-02 lot # 65045972; psn rev 6mm off stem 15x135 catalog # 42-5606-135-15 lot # 64669677; psn fem post aug sz9 15mm catalog # 42-5568-066-15 lot # 64363757; psn fem distal aug sz9 10mm catalog # 42-5566-066-10 lot # 64336306; tm femoral central cone sz med catalog # 42-5450-010-12 lot # 64470412; all poly pat ve 32 mm dia catalog # 42-5402-000-32 lot # 64941145.Device evaluated by mfr: customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported patient underwent a right revision procedure seven weeks post implantation due to articular surface prosthesis fracture and infection.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6- health impact - clinical code- unspecified infection is n/a which was reported on initial report.Reported event was unable to be confirmed due to limited information received from the customer.Visual evaluation of the returned device shows signs of use and the dovetail was flared out.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.X-ray review indicates there is varus alignment of the knee with narrowing of the medial compartment.Although nonspecific, findings can be seen with polyethylene wear.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
It was reported patient underwent a right revision procedure seven weeks post implantation due to articular surface prosthesis fracture.Attempts to obtain additional information have been made; however, no more is available.

• Brand Name: PERSONA ARTICULAR SURFACE FIXED BEARING CONSTRAINED CONDYLAR KNEE (CCK)
• Common Device Name: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12590459
• Report Number: 0001822565-2021-02853
• Device Sequence Number: 17220076
• Product Code: JWH
• UDI-Device Identifier: 00889024555303
• UDI-Public: (01)00889024555303(17)240731(10)64472573
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 42522800710
• Device Lot Number: 64472573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• 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: 09/15/2021
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2019
• 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 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 79 KG