MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ENDO II MOD ENDO HEAD SZ 53; PROSTHESIS, HIP

Model Number N/A

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/28/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Cocomitant medical products: catalog#: 139247 endo ii taper insert std 0mm t lot#: 160270, catalog#: 110010247 g7 osseoti 4 hole shell 58mm g lot#: 6819555, catalog#: 110024465 g7 dual mobility liner 46mm g lot#: 371300, catalog#: 00625006525 bone scr 6.5x25 self-tap lot#: 64984806, catalog#: 00625006525 bone scr 6.5x25 self-tap lot#: j6917785, catalog#: 00625006530 bone scr 6.5x30 self-tap lot#: j7126858, catalog#: 00625006525 bone scr 6.5x25 self-tap lot#: j6864830, catalog#: 650-1055 cer bioloxd option hd 28mm lot#: 3087401, catalog#: 650-1068 cer option type 1 tpr sleve +6 lot#: 3063684, catalog#: 110031013 vivacit-e dm bearing 28x46mm lot#: 64912250, catalog#: 163665 28mm dia cocr mod hd +9mm nk lot#: 64998701.The device will not be returned for analysis, as the device was requested but not returned by the hospital; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-00638.

Event Description

It was reported that the patient underwent a revision procedure for a conversion of a hemi hip to a total hip arthroplasty due to progression of degenerative joint disease (djd).Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: ENDO II MOD ENDO HEAD SZ 53
• 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: 13840398
• MDR Text Key: 287544965
• Report Number: 0001825034-2022-00639
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 00880304221840
• UDI-Public: (01)00880304221840(17)300402(10)492360
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K984028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2022

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
• Device Catalogue Number: 12-139030
• Device Lot Number: 492360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2022
• Initial Date FDA Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male