MAUDE Adverse Event Report: ZIMMER, INC. ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) LEFT 14 MM HEIGHT; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problem Rash (2033)

Event Date 07/05/2016

Event Type  Injury  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.This report is number 4 of 5 mdrs filed for the same patient (reference 3007963827-2017-00002 , 0002648920-2017-00027, 3007963827-2017-00003, 0001822565-2017-00307, & 0001822565-2017-00310).

Event Description

Patient alleged experiencing left knee rash approximately five months post-implantation.No additional information provided.

Manufacturer Narrative

Event date is unknown.Concomitant medical products- all poly patella cemented # 42540000029 lot # 63339813, femur cemented cruciate retaining (cr) narrow left # 42502006401 lot # 63092440, tibia cemented 5 degree stemmed left # 42532007101 lot # 63347843, palacos r 1x40 single # 00111214001 lot # 80364394.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.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: ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) LEFT 14 MM HEIGHT
• 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: 6267920
• MDR Text Key: 65453272
• Report Number: 0001822565-2017-00307
• 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: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 42512000514
• Device Lot Number: 62500751
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2013
• 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): Other
• Patient Age: 49 YR