MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM - REVISION TAPER - NITRIDED CEMENTLESS; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	11/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item number 00223200418 item name cable cerclage cable withcrimp 1.8 mm dia.635 mm length lot # 63330780.Item number unk shell item name unk shell lot #unk.Item number unk liner item name unk liner lot #unk.Item number 00999601735 item name femoral body -revision - nitrided -porous cementless12/14 neck taperstandard 40 mm neckoffset lot #u 63267124.Item number 00801802801 item name femoral head sterile product do not resterilize 12/14 taper lot # 62778820.Report source: (b)(6).The device will not be returned for analysis it was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that patient underwent total hip arthroplasty.Subsequently, patient underwent a revision procedure 4 years post implantation due to implant breakage and infection.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Review of sterile certifications has confirmed that it is unlikely the device caused any patient infection.Radiographs were provided and reviewed by a health care professional.Review identified the stem had fractured.Significant findings include good distal fixation, unable to determine what lead to stem fracture, stem in neutral position with adequate support.Dhr was reviewed and no discrepancies were found.The identified zimmer biomet devices were implanted with competitor devices and compatibility has not been confirmed.It is unknown if the off-label usage may have caused or contributed to the reported event.A definitive root cause cannot be determined.A summary of the investigation has been sent to the customer.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.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: FEMORAL STEM - REVISION TAPER - NITRIDED CEMENTLESS
• 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: 12865333
• Report Number: 0001822565-2021-03318
• Device Sequence Number: 11106973
• Product Code: JDI
• UDI-Device Identifier: 00889024160767
• UDI-Public: (01)00889024160767(17)251130(10)63207181
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2022

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 Expiration Date: 11/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 00998201513
• Device Lot Number: 63207181
• 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: 11/04/2021
• Supplement Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2015
• 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: Male