MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. PERSONA CEMENTED ALL POLY PATELLA 35MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Pain (1994); Rupture (2208)

Event Date 10/09/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products - persona natural stemmed tibial component size e left catalog #: 42532007101 lot #: 63189523, zimmer persona ps polyethylene articular surface size 10 catalog #: 42512400710 lot #: 62762730, nexgen lps-flex option femoral component size f left catalog #: 00596801651 lot #: 63506651.The product was evaluated through manufacturing review and the reported event was confirmed through review of medical records.The devices history records were reviewed and no discrepancies relevant to the reported event were identified.Review of medical records received confirmed that the patient underwent a third retinacular repair and reconstruction with allograft due to left knee pain, patellar instability with obvious dislocation with knee flexion and a palpable defective retinaculum.The surgeon reported that the retinaculum had failed at the central portion of the patella.The quadriceps portion was healed, as was the distal most aspect of the retinaculum.Extensive scarring was noted laterally, causing the patella to sublux.The surgeon aggressively cauterized to release the lateral retinaculum which ¿left a significant defect laterally¿.He then used an achilles allograft to repair it.Per the package insert for the persona knee, pain is one of the known adverse effects of the tka procedure.Compatibility of the implants was also reviewed, and per the package insert for nexgen cr-flex and lps-flex knees, nexgen femoral components are not compatible with persona articular surfaces or tibial components.However, a definitive root cause of the tendon tear and pain leading to retinaculum repair or effect of the off-label use of the nexgen femur cannot be determined.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 event, please see associated reports: 0001822565-2018-03861.This report was previously submitted erroneously on apr 6, 2018 and may 22, 2018 under manufacturing report number 0001822565-2018-02051.

Event Description

It is reported that the patient underwent a left knee retinaculum repair and reconstruction with allograft four months following her last left knee procedure due to recurrent retinacular rupture, continued pain and gross patellar component instability.

• Brand Name: PERSONA CEMENTED ALL POLY PATELLA 35MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7751466
• MDR Text Key: 116054098
• Report Number: 0002648920-2018-00582
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42540000035
• Device Lot Number: 63432243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2016
• 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: 74 YR
• Patient Weight: 84