MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH FITMORE, HIP STEM, UNCEMENTED, OFFSET B (EXTENDED)/4, TAPER 12/14; PROSTHESIS, HIP, HEMI- FEMORAL

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	06/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported in a clinical study that a patient experienced a periprosthetic fracture of the tip of the greater trochanter.The line of the fracture did not touch the stem.Painkillers was the only treatment given.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: - bioloxâ® delta, ceramic femoral head, s, 㸠32/-3.5, taper 12/14; item# 00-8775-032-01, lot # unknown.Bioloxâ® delta ceramic taper liner, size hh / 32 i.D.For use with 50 mm o.D.Size hh shell; item# 00-8775-009-32, lot # unknown.Allofitâ® it alloclassicâ®, shell for acetabulum, uncemented, 50/hh; item# 00-8755-050-00, lot # unknown.Report source ¿ foreign ¿ sweden.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
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Device is used for treatment.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: all of the images demonstrate what appears to be a longitudinally oriented minimally displaced fracture involving the lesser trochanter of the right femur.The fracture does not appear to extend to the level of the hardware.No significant displacement is noted on the frontal views, but on the lateral view, there appears to be a cortical step-off which is seen anteriorly (to the left) of the intertrochanteric region.Hardware and bones otherwise grossly unremarkable.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: FITMORE, HIP STEM, UNCEMENTED, OFFSET B (EXTENDED)/4, TAPER 12/14
• Common Device Name: PROSTHESIS, HIP, HEMI- FEMORAL
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 15968819
• Report Number: 0009613350-2022-00633
• Device Sequence Number: 5107609
• Product Code: KWY
• UDI-Device Identifier: 00889024591646
• UDI-Public: (01)00889024591646(17)201031(10)2572459
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K192236
• 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,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 01.00551.304
• Device Lot Number: 2572459
• 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: 11/16/2022
• Supplement Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2010
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 43 KG