MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PEROSNA PARTIAL KNEE SYSTEM ARTSURFACE PROVISIONAL MEDIAL SIZE E 8MM THICKNESS; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet and 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 while trailing a partial knee arthroplasty, the provisional bearing cracked.No patient consequence was reported.
Additional Manufacturer Narrative
Visual examination of the returned product identified signs of repeated use and a crack.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Device history record was reviewed and no discrepancies were found.A definitive root cause cannot be determined.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.
Event or Problem Description
No additional information reported.

• Brand Name: PEROSNA PARTIAL KNEE SYSTEM ARTSURFACE PROVISIONAL MEDIAL SIZE E 8MM THICKNESS
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9081704
• Report Number: 0001825034-2019-04099
• Device Sequence Number: 11463724
• Product Code: HSX
• UDI-Device Identifier: 00880304809840
• UDI-Public: (01)00880304809840
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2020

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: 42518100508
• Device Lot Number: 63727021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 09/18/2019
• Supplement Report FDA Received Date: 01/29/2020
• 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