MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PARTIAL KNEE ARTICULAR SURFACE PROVISIONAL MEDIAL SIZE F 8MM; PROVISIONAL, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source - foreign: (b)(6).The complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned device showed signs of repeated use (nicked/gouged) and the device was fractured.Dimensional analysis determined that the product was conforming to print specifications where measured.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
It was reported that during kit inspection at the distribution warehouse, the articular surface provisional was identified to be fractured.Attempts have been made, however, no additional information is available at this time.

• Brand Name: PERSONA PARTIAL KNEE ARTICULAR SURFACE PROVISIONAL MEDIAL SIZE F 8MM
• Common Device Name: PROVISIONAL, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11590143
• Report Number: 0001825034-2021-00477
• Device Sequence Number: 14672971
• Product Code: HSX
• UDI-Device Identifier: 00880304809901
• UDI-Public: (01)00880304809901(10)637225246
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2021

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: 42518100608
• Device Lot Number: 63725246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 03/30/2021
• 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