MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER UNICOMPARTMENTAL KNEE PRECOAT TIBIAL COMPONENT SIZE 2; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Date 03/11/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices - zimmer unicompartmental knee high flex precoat cemented femoral component, catalog #: 00584201301, lot #: 64695976.Zimmer unicompartmental knee articular surface size 2 8mm, catalog #: 00584202208, lot #: 64683524.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded.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 patient; please see all reports associated with this event: 0001822565-2023-00864, 0001822565-2023-00866.

Event Description

It was reported that the patient underwent a left knee arthroplasty revision to address recurrent pain, swelling and suspected metal allergies approximately eight (8) years post-operatively.Attempts have been made, however, no additional information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h10.Medical records received were reviewed and confirmed significant inflammation, increase in activity present in the left knee joint, grade 4 chondral wear, and a synovectomy during the revision.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: ZIMMER UNICOMPARTMENTAL KNEE PRECOAT TIBIAL COMPONENT SIZE 2
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16652332
• MDR Text Key: 312405938
• Report Number: 0001822565-2023-00865
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00889024193604
• UDI-Public: (01)00889024193604(17)300331(10)64689784
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K033363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• 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: 00584200201
• Device Lot Number: 64689784
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female