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

Model Number N/A

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

Patient Problems Pain (1994); Rupture (2208)

Event Date 06/20/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: persona size e tibia, catalog #: 42532007101, lot #: 63189523; zimmer persona posterior stabilized fixed bearing polyethylene articular surface size 10mm left, catalog #: 42512400710, lot #: 62762730; zimmer nexgen lps-flex tivanium femur size f, catalog #: 00596801651, lot #: 63506651.It was indicated by the complainant that the product would not be returned to zimmer biomet for evaluation, as the device remains implanted.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 provided identified at least one fall since the patient's procedure in (b)(6) 2017.There was palpable defect noted in the medial retinaculum with pretibial edema, erythema and obvious lateral subluxation.The operative report confirms that the patient suffered from left knee retinacular disruption with continuous left knee pain.After soft and hard tissue resections, it was observed that there was no evidence of infection, but that there was an obvious traumatic disruption of the retinaculum at the level of the vastus medialis oblique extending to the inferior pole of the retinaculum.The edges of the retinaculum were debrided sharply down to normal tissue, vancomycin powder was used and the retinaculum was repaired.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: 0001822565-2018-03859.This report was previously submitted erroneously on apr 6, 2018 and may 22, 2018 under manufacturing report number 0001822565-2018-02049.

Event Description

It is reported that the patient underwent a left knee retinaculum repair two months following her last left knee procedure due to retinacular rupture and increased pain.The patient relayed she had fallen once since her last procedure.No additional patient consequences were reported.

• Brand Name: ZIMMER 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: 7751459
• MDR Text Key: 116053346
• Report Number: 0002648920-2018-00580
• 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: company representative,consum
• 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?: No
• 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: 73 YR
• Patient Weight: 84