MAUDE Adverse Event Report: ZIMMER, INC. CPS TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 3-5 CD TOP; INSTRUMENT, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported the tibial articular surface provisional fractured.No known patient involvement.

Manufacturer Narrative

The information provided on this form was previously submitted under manufacturing report number 0001822565-2017-00376.

• Brand Name: CPS TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 3-5 CD TOP
• Type of Device: INSTRUMENT, 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: 6296971
• MDR Text Key: 66435781
• Report Number: 0001822565-2017-00536
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK123459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42527600410
• Device Lot Number: 62610937
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/03/2017
• Initial Date FDA Received: 02/02/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/29/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1