MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL STEM 12/14 NECK TAPER STD. OFFSET SIZE 2 130 MM STEM LENGTH; PROSTHESIS, HIP

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	04/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date of birth: unknown day in (b)(6).Concomitant medical products: catalog#: 010000662 g7 pps ltd acet shell 50d lot#: 6281224.Catalog#: 110024462 g7 dual mobility liner 40mm d lot#: 881640.Catalog#: ep-200146 act artic e1 hip brg 28x40mm s46 dia28 lot#: 498960.Catalog#: 00801802802 femoral head sterile product 12/14 taper lot#: 64309623.Report source: foreign: (b)(6).The device will not be returned for analysis, due to the device being discarded; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a revision procedure approximately two years post implantation due to periprosthetic fracture.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, g3, g6, h2, h3, h6, h10 reported event was unable to be confirmed due to limited information received from the customer.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The event was confirmed with medical records and x-rays received.Review of the available records identified the following: patient underwent revision of right hip due to femur fracture.Patient fell and has pain and unable to lift the leg.Right hip lateral periprosthetic femur fracture with trochanteric minor was noted.The op notes identified communized and dislocated fracture in several major fragments.Xray identified a recent fall resulting in tearing (avulsion) of entire trochanter major, treating conservatively.Additional information does not change the root cause of previous investigation.A definitive root cause cannot be identified.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
It was reported that a clinical study patient underwent a revision procedure approximately 2 years post implantation as a result of the patient falling at home.Patient is unsure if the fall was a result of trip or loss of balance.Patient was found to have femur fracture with large fragments of trochanter.The g7 cup was retained.No further event information available at the time of this report.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER STD. OFFSET SIZE 2 130 MM STEM LENGTH
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12108027
• Report Number: 0002648920-2021-00180
• Device Sequence Number: 14622366
• Product Code: JDI
• UDI-Device Identifier: 00889024145771
• UDI-Public: (01)00889024145771(17)280930(10)64152405
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K191735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• 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,Followup
• Report Date (Section B): 11/16/2021

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00811400200
• Device Lot Number: 64152405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 10/06/2021; 11/09/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 10/08/2021; 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 55 KG