MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ARTICULAR SURFACE FIXED BEARING; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Complaint sample was evaluated and the reported event was confirmed.All explanted devices were returned, and cement was found on the tibia, and wear on the articular surface.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Per package inserts: wear and loosening are known adverse effect of this system.The wear in the poly might cause the tibia to loose as stated in the reported event.However, sufficient information was not provided to identify the cause of the articular surface wear.Therefore, a definitive root cause cannot be determined.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.Concomitant medical products: 42532007902, tibial component, lot # 63656203; 42502806802, femur, lot # 63351597.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2019-00287.
Event or Problem Description
It was reported that the patient underwent a revision of the knee due to tibial loosening and poly wear.Attempts have been made and no further information has been provided.

• Brand Name: ARTICULAR SURFACE FIXED BEARING
• 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: 9167207
• Report Number: 0002648920-2019-00727
• Device Sequence Number: 11465895
• Product Code: MBH
• UDI-Device Identifier: 00889024243149
• UDI-Public: (01)00889024243149
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K121771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2019

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: 05/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 42522200613
• Device Lot Number: 63057860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 55 YR