MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL FEMUR CEMENTED SIZE 4 RIGHT MEDIAL; 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	04/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2020-01516, 0001825034-2020-01517.Concomitant medical products: partial tibial cemented size d right medial, item# 42538000402, lot# 63610813.Partial articular surface right medial size d 9 mm thickness, item# 42528200409, lot# 63442433.Report source - (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.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 is continuing to experience ongoing pain in the right knee approximately two years and two weeks post implantation.The pain in the right knee (medial aspect) has worsened.There are no obvious changes on x-rays compared with twelve months ago.Spect ct scan ordered and vitamin d levels checked.The patient will be seen again this month.There is no additional information at this time.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined that this device is related to ongoing issues previously reported on 0001825034-2019-00602.
Event or Problem Description
Upon reassessment of the reported event, it was determined that this device is related to ongoing issues previously reported on 0001825034-2019-00602.

• Brand Name: PARTIAL FEMUR CEMENTED SIZE 4 RIGHT MEDIAL
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9947761
• Report Number: 0001825034-2020-01515
• Device Sequence Number: 3257628
• Product Code: HSX
• UDI-Device Identifier: 00880304808553
• UDI-Public: (01)00880304808553
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2020

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 Model Number: N/A
• Device Catalogue Number: 42558000402
• Device Lot Number: 63767241
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 04/16/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 66