MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM- ARTICULAR SURFACE; PROSTHESIS, KNEE

Catalog Number 42512400710

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 01/12/2015

Event Type  Injury  

Manufacturer Narrative

Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2016-01264, 3007963827-2017-00222, 0002648920-2017-00338.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.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.Concomitant medical products: femur cemented posterior stabilized (ps) narrow left size 7, catalog#: 42500006201, lot: 62845273; natural tibia cemented 5 degree stemmed left size e, catalog# 42532007101, lot:# 62771192; all-poly patella cemented 32 mm diameter, catalog# 42540200032, lot# 62884119.

Event Description

It is reported that the patient is experiencing pain and unknown problems with her implant.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM- ARTICULAR SURFACE
• 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: 6593777
• MDR Text Key: 76043910
• Report Number: 0001822565-2017-03580
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 42512400710
• Device Lot Number: 62590696
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Weight: 91