MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METAL PS MONOBLOCK TIBIAL COMPONENT: YELLOW, SIZE 3 C-D, 10MM; PROSTHESIS, KNEE

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Limited Mobility Of The Implanted Joint (2671)

Event Date 03/09/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: nexgen complete knee solution, trabecular metal standard primary patella, catalog#: 00587806529, lot#: 63622755, femur trabecular metal posterior stabilized (ps) standard porous, catalog#: 42500805801, lot#: 62789560.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a study patient underwent left total knee arthroplasty.Subsequently, at the two year clinical study visit, the patient reported severe pain, taking daily nsaids, decrease in range of motion, and dissatisfaction.No revisions or adverse events were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, g4, g7, h1, h2, h3, h6, h10.No product was returned as it remains implanted, therefore visual and dimensional evaluations could not be performed.The device history records for the item were reviewed for deviations and/ or anomalies with no deviations/ anomalies identified.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Crf report was provided and reviewed by a health care professional.Review of the available records identified the following: no complication was noted during the initial surgery.On march 01, 2018, the patient experienced pain for 2 years and administrating nsaid daily with flexion 92.Also, it was noted patient experiencing swelling, popping, stiffness.No other issue was noted.With the information available a definitive root cause cannot be determined.

Event Description

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

• Brand Name: TRABECULAR METAL PS MONOBLOCK TIBIAL COMPONENT: YELLOW, SIZE 3 C-D, 10MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 9993050
• MDR Text Key: 189145467
• Report Number: 3005751028-2020-00038
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024310247
• UDI-Public: (01)00889024310247(17)220831(10)63700390
• Combination Product (y/n): N
• PMA/PMN Number: K031462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00588605310
• Device Lot Number: 63700390
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 82