MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR FEMORAL STEM CEMENTLESS SIZE 9; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Material Erosion (1214); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Metal Related Pathology (4530)
Date of Event	09/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision procedure approximately three (3) years and four (4) months post implantation due to wear.No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Catalog#: 00784800200 modular neck k 12/14 neck taper lot#: 62837931.Catalog#: 00620205222 shell porous with cluster holes 52 mm lot#: 63171564.Catalog#: 00630505036 liner standard 3.5 mm offset 36 mm i.D.Lot#: 63601474.Catalog#: 00801803602 femoral head sterile product 2/14 taper lot#: 63494290.Catalog#: 00625006520 bone screw self-tapping 6.5 mm dia.20 mm length lot#: 63585012.Catalog#: 00625006525 bone screw self-tapping 6.5 mm dia.25 mm length lot#: 63596930.Medical records were provided and reviewed by a health care professional.A review of the available records identified the following: the patient underwent a left total hip arthroplasty.Zimmer biomet components were implanted without complications.The patient underwent a revision procedure.Significant poly wear was noted during the procedure.There was little inflammation within the joint but no accumulated synovial fluid.All products were revised.No other complication/finding related to the reported event was noted.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2021-00355.

• Brand Name: MODULAR FEMORAL STEM CEMENTLESS SIZE 9
• 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: 13758353
• Report Number: 0001822565-2022-00719
• Device Sequence Number: 5942857
• Product Code: LPH
• UDI-Device Identifier: 00889024132627
• UDI-Public: (01)00889024132627(17)270331(10)63622444
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K182678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00771300900
• Device Lot Number: 63622444
• 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: 03/03/2022
• Initial Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2017
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female