MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA VE ALL POLY PATELLA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 11/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).:concomitant medical products persona articular surface fixed bearing ultracongruent (uc) right catalog # 42522200611 lot # 6395737, persona cr narrow femoral catalog # 42502007002 lot # 63512703, persona stemmed tibia catalog # 42532008302 lot # 63627453, headed screw 48 mm length catalog # 00579104100 lot # 63495278, headed screw 48 mm length catalog # 00579104100 lot # 63565449, headed screw 48 mm length catalog # 00579104100 lot # 63612132, headed screw 48 mm length catalog # 00579104100 lot # 63631220, psi psn pref cr pin guides psi psn pref cr pin guides catalog # 00597000033 lot # 17.289116, psi psn pref cr pin guides psi psn pref cr pin guides catalog # 00597000033 lot # 17.289666, 2.5 mm female hex screw 25 mm length catalog # 42509902525 lot # 63649495, 2.5 mm female hex screw 25 mm length catalog # 42509902525 lot #63649497.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001822565-2018-06987, 0001822565-2019-04032, 3007963827-2019-00267.The following sections could not be completed because the lot information could be: lot #: 63574821, expiration date: feb 28, 2022, manufacture date: mar 7, 2017.Or the lot # information could be: lot #: 63474786, expiration date: oct 31, 2021, manufacture date: oct 27, 2016.Discarded.

Event Description

It was reported the patient underwent a revision procedure due to infection and only the polyethylene articular surface was removed and replaced.Subsequently, the patient was revised again five days later due to infection and had all products, which were initially implanted approximately fifteen months prior, removed and replaced with antibiotic cement spacer molds.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D4: udi # : (b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Per package insert 87-6204-022-23 rev a persona the personalized knee system: infection is a known adverse effect of this system 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: PERSONA VE ALL POLY PATELLA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9086088
• MDR Text Key: 159174109
• Report Number: 0001822565-2019-04034
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• PMA/PMN Number: K121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: N/A
• Device Catalogue Number: 42540200038
• Device Lot Number: 63574821
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/05/2019
• Initial Date FDA Received: 09/19/2019
• Supplement Dates Manufacturer Received: 09/30/2019
• Supplement Dates FDA Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention