MAUDE Adverse Event Report: ZIMMER INC UNKNOWN ZIMMER BIGLIANI FLATOW IMPLANT; SHOULDER IMPLANT

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 03/28/2016

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 was revised due to the humeral stem being placed too high superior.

Manufacturer Narrative

This information was reported in error on mdr #0001822565-2016-01166-1 on (b)(6) 2016.No device or photos were received; therefore the condition of the component is unknown.Device history records cannot be reviewed since the part and lot number is unknown.This device is used for treatment.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Post operative x-ray from an unknown date was provided for review.Third party review of the x-ray confirms that stem does not appear angulated and no lucency or fracture is seen.It has also been noted in the review that "it does appear that the superior portion of the hardware is positioned at the upper limit of normal to slightly increased (near or above 5 mm) with respect to the greater tuberosity, which raises suspicion that the hardware was not fully delivered into the humerus (presumably from being oversized or resistance to insertion)." product history search cannot be completed since the part and lot number is unknown.Patient's activity level and adherence to rehabilitation protocol is unknown.The investigation could not verify or identify any evidence of product contribution to the reported problem.

• Brand Name: UNKNOWN ZIMMER BIGLIANI FLATOW IMPLANT
• Type of Device: SHOULDER IMPLANT
• 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: 5568346
• MDR Text Key: 42375753
• Report Number: 1822565-2016-01166
• Device Sequence Number: 1
• Product Code: KWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2016
• 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
• Date Manufacturer Received: 08/05/2016
• 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): Required Intervention
• Patient Age: 76 YR