MAUDE Adverse Event Report: ZIMMER, INC. ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) LEFT 12 MM HEIGHT; PERSONA CR VE ARTICULAR SURFACE

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Pain (1994); Ambulation Difficulties (2544); No Information (3190)

Event Date 08/11/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: zimmer persona cr femoral porous, standard, size 9, left, catalog #42502806601 lot# 62397938, zimmer persona two-peg trabecular metal tibia, tm size g, catalog #42530007901 lot#62428602, zimmer nexgen trabecular metal standard primary patella size 35 mm catalog # 00587806535 lot #62382685.Complaint operative notes were evaluated and the reported event was confirmed.No devices or photos were received; therefore the condition of the components are unknown.Review of the primary operative notes confirms that the patient underwent a left total knee arthroplasty due to severe degenerative joint disease of left knee.Trials were inserted and range of motion and stability were checked.The final components were placed with cement less technique and stability was rechecked.The surgeon followed the right technique.Review of the revision op notes confirms that the patient underwent a revision of left total knee arthroplasty due to instability, including femur as well as tibial component.X-rays demonstrated apparent satisfactory positioning of his components without any evidence of loosening.Pain started after several months of initial surgery and patient was unresponsive to all treatment efforts.The tibial component was well fixed.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required as no were trends identified.Per the persona knee system package insert instability is a known risk of this procedure.A definitive root cause cannot 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

It was reported that the patient had revision surgery due to a recalled zimmer persona trabecular metal tibial implant.But our investigation shows patient underwent a revision of left total knee arthroplasty due to instability.

Event Description

It was reported that the patient had initial left total knee arthroplasty.Subsequently, was revised due to pain, ambulating difficulties, use of assistive device and instability approximately on (1) year, nine (9) months post primary implantation.

Manufacturer Narrative

The reported event was confirmed by visual evaluation of received product which noted nicks, gouges and the dovetail feature was flared out.The root cause remains undetermined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) LEFT 12 MM HEIGHT
• Type of Device: PERSONA CR VE ARTICULAR SURFACE
• 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 ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6480190
• MDR Text Key: 72357748
• Report Number: 0001822565-2017-02139
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 42512000612
• Device Lot Number: 62338843
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 09/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR