MAUDE Adverse Event Report: ZIMMER, INC. PERSONA ARTICULAR SURFACE FIXED BEARING CONSTRAINED POSTERIOR PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Hematoma (1884); Blood Loss (2597)

Event Date 06/21/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6). The complaint device is not expected for return currently, but a supplemental medwatch 3500a will be submitted upon receipt of additional information.

Event Description

It was reported that the patient underwent a revision surgery due to hematoma and bleeding following initial knee arthroplasty approximately one (1) month prior. Attempts to obtain additional information are in progress, however no further information is available at this time.

Manufacturer Narrative

This follow up report is being submitted to relay additional information. Reported event was unable to be confirmed due to limited information received from the customer. Dhr was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no were trends identified. Per the persona package insert soft tissue damage and delayed wound healing are listed as known potential adverse effects. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.

• Brand Name: PERSONA ARTICULAR SURFACE FIXED BEARING CONSTRAINED POSTERIOR
• Type of Device: PROSTHESIS, KNEE
• 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: 6730969
• Report Number: 0001822565-2017-04946
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK123459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 11/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 42512600716
• Device Lot Number: 62886005
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2014
• 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 Outcome(s): Hospitalization; Required Intervention