MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL FEMUR CEMENTED SIZE 6 LEFT MEDIAL; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Swelling (2091); Reaction (2414)
Date of Event	10/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item#:42538000701, partial tibial cemented size g left medial, lot#: 63775672.Item#:unknown, bcm-palacos-standard-unk, lot#: unknown.Item#:unknown, bcm-gentamycin-unknown, lot#: unknown.Item#:42518200708, partial articular surface left medial size g 8 mm thickness, lot#: 63707718.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its 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: 0001825034 - 2020 - 02152.
Event or Problem Description
It is reported the patient had an initial left partial tkr, and subsequently was revised approximately 20 months later due to pain, swelling, and metal allergy.
Additional Manufacturer Narrative
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 3007963827 - 2020 - 00170.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: PARTIAL FEMUR CEMENTED SIZE 6 LEFT MEDIAL
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10096157
• Report Number: 0001825034-2020-02151
• Device Sequence Number: 14299463
• Product Code: HSX
• UDI-Device Identifier: 00880304808492
• UDI-Public: (01)00880304808492
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2020

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: 42558000601
• Device Lot Number: 63700337
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/04/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 07/06/2020
• 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: 81