MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL TIBIAL CEMENTED SIZE G RIGHT 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 01/28/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Associated products : item#:42558000602; partial femur cemented size 6 right medial lot#:63760789.Item#:42528200708; partial articular surface right medial size g 8 mm lot#:63784873.Item#:unknown; palacos with gentamycin lot#:unknown.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: 3007963827-2020-00171.

Event Description

It was reported that a clinical study patient underwent a right knee tka approximately two years ago.Subsequently the patient had a revision after experiencing pain and inflammation due to a metal allergy.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.Device did not cause or contribute to the event.The initial report was forwarded in error and should be voided.

Event Description

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

• Brand Name: PARTIAL TIBIAL CEMENTED SIZE G RIGHT MEDIAL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10233163
• MDR Text Key: 197748716
• Report Number: 0001822565-2020-02388
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00880304812734
• UDI-Public: (01)00880304812734
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• 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: 42538000702
• Device Lot Number: 63720352
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 81