MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE WITH HINGE POST EXTENSION SCREW ENCLOSED; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: all poly patella standard size 35 mm diameter 9.0 mm thickness cemented, item# 00597206535, lot# 64325356.Stem extension straight 10mm dia x 100mm length(combined length 145mm), item# 00598801010, lot# 64413907.Tibial component precoat size 3, item# 00588000300, lot# 64393895.Stem extension straight 13mm dia x 100mm length(combined length 145mm), item# 00598801013 ,lot# 64454566.Femoral component option for cemented use only size d right, item# 00588001402, lot# 64230855.Report source - (b)(6).Customer has not indicated whether or not 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 eight months¿ post implantation due to post-surgical pain.It is further reported that the screw backed out of the hinge post.There is no additional information available at this time.
Event or Problem Description
Upon further investigation it was determined that this report was submitted in error.Additional information received indicates that this complaint is a duplicate of (b)(4) and the event will be reported under that complaint number.
Additional Manufacturer Narrative
Upon further investigation it was determined that this report was submitted in error.Additional information received indicates that this complaint is a duplicate of (b)(4) and the event will be reported under that complaint number.

• Brand Name: ARTICULAR SURFACE WITH HINGE POST EXTENSION SCREW ENCLOSED
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10178435
• Report Number: 0001822565-2020-02215
• Device Sequence Number: 11533794
• Product Code: JWH
• UDI-Device Identifier: 00889024199309
• UDI-Public: (01)00889024199309
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 00588004012
• Device Lot Number: 64382844
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 11/05/2020
• 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