MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN SHELL; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Date 06/07/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 51-104110 ¿ taperloc stem ¿ 2138576, 650-1064 ¿ ceramic taper sleeve ¿ 818250, 650-1057 ¿ ceramic head ¿ 171090, unknown liner ¿ unknown part and lot.Reported event was confirmed by review of operative notes.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2018 -09829, 0001825034 -2018 -09831, 0001825034 -2018 -09832, 0001825034 -2018 -09833.

Event Description

It was reported patient underwent a right hip revision approximately 1 year post implantation.During the surgery, patient lost 1550ml of blood and received 1 unit of packed red blood cells.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: UNKNOWN SHELL
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7989788
• MDR Text Key: 124492279
• Report Number: 0001825034-2018-09835
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/18/2018

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
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 10/22/2018
• 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: 66