MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) LEFT 13 MM HEIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 3007963827-2019-00248.Concomitant medical products: articular surface fixed bearing cruciate retaining (cr) left item# 42512000513, lot# 63544578.Report source - (b)(6).Customer has indicated that the product will be returned to zimmer biomet for investigation.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 a patient was revised approximately one year, ten and a half months¿ post implantation due to pain.Patient presented with localized pain, anterior knee joint and proximal tibia.Surgeon requested bone scan and second opinion from a colleague.Bone scan 'lit up', underneath lateral tibial baseplate and patella.Surgeon believed this was evidence of a loose tibia and booked patient in for a revision of tibial baseplate and patella resurfacing.During revision the surgeon struggled to remove the tibial component and conceded it was not loose.Commitment was unfortunately already made to remove the baseplate.Once tibia was removed component was further assessed, good cement adherence to the tibial component and cement-bone interdigitation.Patella resurfaced and tibial art surface upsized.There is no additional information at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b4, b5, g4, g7, h1, h2, h3, h6, and h10.The reported event is not confirmed.Visual examination of the provided pictures identified the tibial component had been revised with bone cement remaining attached to the distal face and the stem.The articular surface can also be seen; however, detailed analysis could not be completed as the photographs do not clearly show the surface of the device.Radiographs were provided and reviewed by a health care professional; however, they were not sent for assessment due to poor image quality and lack of image dates.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.Per the persona knee system package insert, pain is a known potential adverse effect of this procedure.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.

• Brand Name: ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) LEFT 13 MM HEIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8939044
• Report Number: 0001822565-2019-03668
• Device Sequence Number: 2559496
• Product Code: MBH
• UDI-Device Identifier: 00889024235144
• UDI-Public: (01)00889024235144
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 42512000513
• Device Lot Number: 63544578
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 01/27/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 75