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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Pain (1994); Swelling (2091); Reaction (2414)

Event Date 10/29/2019

Event Type  Injury  

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 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.

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 Description

No further event information available at the time of this report.

• Brand Name: PARTIAL FEMUR CEMENTED SIZE 6 LEFT MEDIAL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10096157
• MDR Text Key: 194103170
• Report Number: 0001825034-2020-02151
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00880304808492
• UDI-Public: (01)00880304808492
• Combination Product (y/n): N
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 81