MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL FEMUR CEMENTED SIZE 5 RIGHT MEDIAL; KNEE, PROSTHESIS

Catalog Number 42558000502

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

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 03/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Patient date of birth: (b)(6) 1951.(b)(4).Concomitant medical products: partial tibial cemented size f right medial cat: 42538000602 lot: 63463516 partial articular surface right medial size f 8 mm thickness cat: 42528200608 lot: 63592938.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-04002, 0001822565-2018-04011, 0001822565-2018-04012.Reported event was unable to be confirmed due to limited information received from the customer.Device history record 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.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 Description

Patient reported pain and stiffness post operation.No revision procedure has been reported to date.

• Brand Name: PARTIAL FEMUR CEMENTED SIZE 5 RIGHT MEDIAL
• Type of Device: KNEE, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7746664
• MDR Text Key: 115913234
• Report Number: 0001822565-2018-04002
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 42558000502
• Device Lot Number: 63485124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 76