MAUDE Adverse Event Report: ZIMMER GMBH FITMORE®, HIP STEM, UNCEMENTED, B/6, TAPER 12/14; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10.36mm i.D.Size ii neutral liner use with 52mm o.D.Size ii shell item# 00875101036 lot# 61736670 bioloxâ® delta, ceramic femoral head, s, 㸠36/-3.5, taper 12/14 item# 00877503601 lot# 2596622 allofitâ® it alloclassicâ®, shell for acetabulum, uncemented, 52/ii item# 00875505200 lot# 2597552.G2.Report source: germany.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported a patient had an initial right total hip arthroplasty.Subsequently, approximately 9 years post implantation, experienced a periprosthetic femoral fracture and underwent internal fixation with a plate and cable wires.Diligence is completed 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.The product remains implanted; therefore, visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Medical records were provided and reviewed by a health care professional.The review identified contributing factors of event: elderly, obesity, osteoarthritis.Periprosthetic femoral fracture: internal fixation, plate and cable wire (this indicates an additional procedure was required).With the available information, a definitive root cause could not 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.
Event or Problem Description
Diligence is completed and no further information on the reported event has been provided.

• Brand Name: FITMORE®, HIP STEM, UNCEMENTED, B/6, TAPER 12/14
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 19351317
• Report Number: 0009613350-2024-00185
• Device Sequence Number: 17962227
• Product Code: LZO
• UDI-Device Identifier: 00889024591738
• UDI-Public: (01)00889024591738(17)210630(10)2606096
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 06/21/2024

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: Lay User/Patient
• Device Expiration Date: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 0100551206
• Device Lot Number: 2606096
• 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: 04/23/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2011
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 104 KG