MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ENDO II TAPER INSERT STD 0MM T; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: catalog#: 12-139030 endo ii mod endo head sz 53 lot#: 492360, 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: 0001825034-2022-00639.
Event or Problem 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 TAPER INSERT STD 0MM T
• Common Device Name: 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: 13840391
• Report Number: 0001825034-2022-00638
• Device Sequence Number: 11909704
• Product Code: KWL
• UDI-Device Identifier: 00880304228351
• UDI-Public: (01)00880304228351(17)301112(10)160270
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K984028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 139247
• Device Lot Number: 160270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male