MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH PSN FZN AP CUT BLK SZ 9; PERSONA® PERSONALIZED KNEE SYSTEM

Model Number	N/A
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical product: 5 degree fzn fem angle gde, catalog#: 110040855 ; lot#: unknown.Fuzion ant feeler gde, catalog#: 110040859 ; lot#: unknown.Fzn ff intrmdlry rod 8mm, catalog#: 110040836; lot#: unknown.Fuzion fem rot gde, catalog#: 110040860 ; lot#: unknown.The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.As no lot number was provided, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).In transit to manufacturer.
Event or Problem Description
It was reported that the button (open/lock) had come loose after locking.No effect on the patient.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4), this follow-up report is being submitted to relay additional information.The persona cutting block was provided to the product surveillance team for further investigation and nothing conspicuous other than several minor scratches could be observed.The reported counterpart was not returned for evaluation.Therefore, the condition of the reported counterpart, in particular the interface with the persona cutting block, is unknown.However, it was reported that this device is still being utilized in the clinic.Additionally, two pictures of the reported products in the operating theater were received.The devices are assembled, covered in bodily fluids and the persona cutting block is set in the lock position.A functional test was performed with the received persona cutting block and an internal counterpart for function control and the reported event could not be reproduced.No functional issues could be identified.Review of the device history records identified no deviations or anomalies during manufacturing.Therefore, the investigation did not identify a nonconformance or a complaint out of box.A definitive root cause for the reported event cannot be determined as the reported counterpart was not returned for evaluation as it is still being utilized in the clinic.The functional test performed with an internal counterpart could not reproduce the reported event.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: PSN FZN AP CUT BLK SZ 9
• Common Device Name: PERSONA® PERSONALIZED KNEE SYSTEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14109910
• Report Number: 0009613350-2022-00233
• Device Sequence Number: 11296272
• Product Code: JWH
• UDI-Device Identifier: 00889024577695
• UDI-Public: (01)00889024577695(11)201111(10)4504086026
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K212129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110040850
• Device Lot Number: 4504086026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/17/2022
• Supplement Date Received by Manufacturer: 09/15/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown