MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. PERSONA CEMENTED STEMMED NATURAL TIBIAL COMPONENT SIZE E LEFT; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Respiratory Acidosis (2482); Respiratory Failure (2484)

Event Date 10/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products ¿ persona tm cruciate retaining narrow porous femoral component size 7 left catalog #: 42502206201 lot #: 63199066, persona ultracongruent vivacit-e articular surface 11mm catalog #: 42512200511 lot #: 62335084, persona all poly patella 35mm catalog #: 42540000035 lot #: 63432243.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the devices remain implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-04158, 0001822565-2018-04159, 0002648920-2018-00623.Device remains implanted.

Event Description

It was reported that the patient experienced status asthmaticus and was immediately admitted to an intensive care unit following knee arthroplasty to treat hypercapnia and respiratory acidosis/failure.No additional patient consequences were reported.

Manufacturer Narrative

The product was evaluated through manufacturing review and the reported event was confirmed through review of medical records.The device history records were reviewed and no discrepancies were identified.The reported issues are related to the procedure and not abnormal to the procedure with no failure detected with the devices.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

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

• Brand Name: PERSONA CEMENTED STEMMED NATURAL TIBIAL COMPONENT SIZE E LEFT
• 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
• MDR Report Key: 7751412
• MDR Text Key: 116050316
• Report Number: 0002648920-2018-00622
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: PK172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 07/17/2019

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: 42532007101
• Device Lot Number: 63189523
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/16/2019
• 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
• Patient Age: 73 YR
• Patient Weight: 84