MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STEM EXTENSION REPLACEMENT SCREW; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Date of Event	05/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: nexgen stemmed tibial component, catalog #: 00598003702, lot #: 64197779.Nexgen articular surface, catalog #: 00596203214, lot #: 63769766.Nexgen all poly patella, catalog #: 00597206632, lot #: 64163561.Cem fem/cem tib/ prlng art surf/xlpe pat, catalog #: 98000200106, lot #: unknown.Taper plug, catalog #: 00596009900, lot #: 64203438.Stem ext replacement screw, catalog #: 00598009000, lot #: 64228338.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to it remains implanted.Multiple mdr reports were filled for this event: 0002648920-2020-00298, 0001822565-2020-02046, 0001822565-2020-02047, 0002648920-2020-00354.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.The contact was sent the investigation results.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.
Event or Problem Description
It was reported that the patient underwent a knee arthroplasty.Subsequently, the patient has been experiencing pain, swelling, and heat in the knee.No revision procedure has been reported to date.Attempt for further information has been made, but no further information has been provided.

• Brand Name: STEM EXTENSION REPLACEMENT SCREW
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10346287
• Report Number: 0001822565-2020-02641
• Device Sequence Number: 3748602
• Product Code: JWH
• UDI-Device Identifier: 00889024217669
• UDI-Public: (01)00889024217669
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,health p
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/30/2020

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: 00598009000
• Device Lot Number: 64228338
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 07/30/2020
• 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: 100