MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER UNICOMPARTMENTAL ARTICULAR SURFACE SIZE 4 12MM; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Pain (1994); Osteolysis (2377)

Event Date 12/10/2019

Event Type  Injury  

Event Description

T was reported that the patient underwent a right knee arthroplasty revision approximately four (4) years post-operatively to address pain, osteolysis and tibial subsidence.Revision operative notes noted no intraoperative complications.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).D10 - concomitant devices - zimmer unicompartmental precoat tibial component right size 4 catalog #: 00584200402 lot #: 63046525, zimmer unicompartmental high flex precoat femoral component catalog #: 00584201602 lot #: 63091336, palacos r 1x40 single bone cement catalog #: 00111214001 lot #: 80964425.Medical records provided confirmed the reported event.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.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001822565-2023-00840.0001822565-2023-00841.

• Brand Name: ZIMMER UNICOMPARTMENTAL ARTICULAR SURFACE SIZE 4 12MM
• 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: 17624285
• MDR Text Key: 321960196
• Report Number: 0001822565-2023-02273
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00584202412
• Device Lot Number: 62923555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2015
• 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): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White