MAUDE Adverse Event Report: ZIMMER INC UNKNOWN ZIMMER IMPLANT; TRAUMA PROSTHESIS

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

(b)(4).There was no product part or lot numbers provided, a complaint review could not be performed.Device history records could not be reviewed as product identification or lot numbers were not provided.The root cause could not be determined by the provided information.As no product was returned; no physical evaluation could be conducted.This device is used for treatment.

Event Description

It is reported that the patient is experiencing pain, swelling, her knee feels hot and tender to the touch.

• Brand Name: UNKNOWN ZIMMER IMPLANT
• Type of Device: TRAUMA PROSTHESIS
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5390810
• MDR Text Key: 36893643
• Report Number: 1822565-2016-00140
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• 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: 12/30/2015

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
• Initial Date Manufacturer Received: 12/30/2015
• Initial Date FDA Received: 01/26/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 79