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

Catalog Number 42530007501

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Pain (1994); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

No devices or photos were received.The part and lot number is unknown.This device is used for treatment.The primary operative notes provided confirm that the patient underwent left total knee arthroplasty on for severe degenerative joint disease.Review of primary operative notes does not indicate root cause.The patient had full extension and full flexion and the patella tracked well.The compatibility could not be assessed and the product history search could not be performed as the part and lot number are unknown.A definitive root cause cannot be determined with the information provided.However, the complaint may be revised upon return of product or further information.

Event Description

It is reported that the patient is experiencing pain, swelling and knee arthroplasty loosening post-operatively.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The primary operative notes provided confirm that the patient underwent left total knee arthroplasty for severe degenerative joint disease.Review of primary operative notes does not indicate a root cause.The patient had full extension and full flexion and the patella tracked well.The compatibility could not be assessed and the product history search could not be performed as the part and lot number are unknown.A definitive root cause cannot be determined with the information provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.A field action was conducted in which zimmer voluntarily removed the persona trabecular metal tibial implant from the field due to a higher than anticipated complaint rate for radiolucent lines and loosening.The device in question was implanted prior to this field action.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.

• Brand Name: NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE F
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; p.o. box 708; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6039418
• MDR Text Key: 57798888
• Report Number: 0001822565-2016-03771
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• PMA/PMN Number: PK121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 42530007501
• Device Lot Number: 62475971
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1266-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 95