MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL POLY PATELLA STANDARD SIZE 29 MM DIAMETER 8.0 MM THICKNESS CEMENTED; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	No Information (3190); Insufficient Information (4580)
Date of Event	11/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 00585002012 - articular surface - 63530803.00585204035 - stem collar - 64073497.00585001296 - polyethylene insert - 64058793.00585007512 - cement shield hinge service kit - 62739301.00585004202 - femoral component - 63917928.00585205015 - fluted stem extension - 64069897.00545001731 - femoral diaphyseal cone - 63768449.00598304027 - screw - 64057985.00588000302 - tibial component - 63548490.00545001341 - tibial cone - 64204230.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-03992.
Event or Problem Description
It was reported that the patient underwent a zss revision procedure due to the patella tracking laterally.It was noted the position of the femur was changed, as well as tissue debridement.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The dhr was reviewed and no discrepancies relevant to the reported event 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 further event information available at the time of this report.

• Brand Name: ALL POLY PATELLA STANDARD SIZE 29 MM DIAMETER 8.0 MM THICKNESS CEMENTED
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 11013403
• Report Number: 0002648920-2020-00529
• Device Sequence Number: 17204046
• Product Code: JWH
• UDI-Device Identifier: 00889024215139
• UDI-Public: (01)00889024215139(17)260930(10)64163932
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/15/2021

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: 09/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 00597206529
• Device Lot Number: 64163932
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 02/16/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention