MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN ZIMMER TRAUMA PROSTHESIS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that a patient is experiencing pain and deterioration of the implant.

Manufacturer Narrative

Device history records could not be reviewed as the lot number is unknown.The product was not returned for review; therefore the exact condition of the device is unknown.This device is used for treatment.A product history search could not be conducted as the part and lot numbers of the implant are unknown.It was reported that the patient was revised due to implant fracture, but operative notes were not provided.Therefore, the complaint cannot be confirmed.A definitive root cause cannot be determined with the information provided.

• Brand Name: UNKNOWN ZIMMER TRAUMA PROSTHESIS
• Type of Device: TRAUMA PROSTHESIS
• 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: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5945498
• MDR Text Key: 54523969
• Report Number: 0001822565-2016-03221
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/17/2016
• Initial Date FDA Received: 09/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 68