MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS SHORT ANCHOR PLUG 14MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	05/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2- japan.H3- customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the compress short anchor plug fractured approximately one year post implantation.It is unknown when the revision will be implemented.Attempts to obtain additional information have been made; however, no more information is available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b4, b5, d2, g1, g3, g6, h1, h2, h3, h6, and h10 no product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: fracture of the junction of the femoral stem and anchor plug proximally is noted.No evidence for disease progression.Overall size of the implant is appropriate.No signs of loosening, wear or radiolucency.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot be determined.Complaint is confirmed from the provided medical records.If any further information is received which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: CPS SHORT ANCHOR PLUG 14MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17009989
• Report Number: 0001825034-2023-01200
• Device Sequence Number: 20551142
• Product Code: KWA
• UDI-Device Identifier: 00880304461635
• UDI-Public: (01)00880304461635(17)280301(10)164820
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 09/19/2023

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: 178556
• Device Lot Number: 164820
• 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: 05/09/2023
• Supplement Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2018
• 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: Other
• Patient Sex: Male