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

Model Number N/A

Device Problems Appropriate Term/Code Not Available (3191); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Swelling (2091); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 08/03/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: associated products : item#:42558000401; partial femur cemented size 4 left medial lot#: 63947026; item#:42518200408; partial articular surface left medial size d 8 mm thickness; lot#: 63714071.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Patient underwent an initial left unilateral tka on one year ago.Subsequently, the patient was revised approximately 9 months later, due to pain, rom limited mobility, radiolucency, loosening, subsidence, and swelling.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g4, g7, h2, h3, h6, h10.The product was evaluated through manufacturing review and the reported event was confirmed through review of medical records.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information 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

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

• Brand Name: PARTIAL TIBIAL CEMENTED SIZE D LEFT MEDIAL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10522447
• MDR Text Key: 206558718
• Report Number: 0001825034-2020-03486
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00880304812666
• UDI-Public: (01)00880304812666
• 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: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42538000401
• Device Lot Number: 64083773
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2020
• 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: 54