MAUDE Adverse Event Report: ZIMMER INC UNKNOWN ZIMMER BIGLIANI/FLATOW HUMERAL STEM; KWR

Device Problem Insufficient Information (3190)

Patient Problem Pulmonary Embolism (1498)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported that the patient had experienced deep vein thrombosis, resulting in a pulmonary embolism and shortness of breath.

Manufacturer Narrative

Other devices used: catalog #unk, unknown standard pegged white bigliani/flatow glenoid, lot #unk, catalog #unk, unknown 46 mm bigliani/flatow humeal head, lot #unk.The provided operative notes are vague, as such; no definitive statements can be made regarding the surgical technique.No devices or photos were received; therefore the condition of the components is unknown.The part and lot numbers of the product are unknown; therefore the device history records could not be reviewed.These products were used for treatment.The complaint history for these products could not be reviewed due to the lack of lot numbers.It could not be confirmed if the devices are an approved and compatible combination.The investigation could not verify or identify any evidence of product contribution to the reported problem.Based on the available information, the need for corrective action is not indicated.A definitive root cause cannot be determined with the information provided.

• Brand Name: UNKNOWN ZIMMER BIGLIANI/FLATOW HUMERAL STEM
• Type of Device: KWR
• 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: 5014325
• MDR Text Key: 23436895
• Report Number: 1822565-2015-01519
• Device Sequence Number: 1
• Product Code: KWR
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 07/29/2015

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/26/2015
• 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: 72