MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING; PROSTHESIS KNEE

Model Number N/A

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

Patient Problem Pain (1994)

Event Date 02/01/2023

Event Type  Injury  

Event Description

It was reported patient underwent a revision procedure fifteen months post implantation due to pain in knee.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

(b)(4).Medical product: articular surface medial congruent (mc) catalog # 42522100311 lot # 64821566.Femur trabecular metal cruciate retaining (cr) catalog # 42502205802 lot # 64894501.Nexgenâ® complete knee solution, trabecular metalâ standard primary patella catalog # 00587806532 lot # 65019535.Biomet bc r 1x40 us catalog # 110035368 lot # az50ba2102.Biomet bc r 1x40 us catalog # 110035368 lot # y11baa2101.Customer has indicated that the product will not be returned because requested but not returned by hospital.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 3007963827-2023-00033 & 0001822565-2023-00485.Not returned by hospital.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Radiograph review indicates there is no issues with anatomic alignment, no signs of loosening, wear, radiolucency, bones appear well mineralized, no fracture or dislocation, large suprapatellar joint effusion and edema in hoffa's fat pad.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: NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING
• 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: 16428909
• MDR Text Key: 310077097
• Report Number: 0001822565-2023-00487
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 00889024510548
• UDI-Public: (01)00889024510548(17)300720(10)64696346
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• 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: 42530006702
• Device Lot Number: 64696346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2020
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 78 KG