MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM PRESS-FIT COLLARLESS 12/14 NECK TAPER; 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	02/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: unknown-unknown cup-unknown.Unknown-unknown head-unknown.Unknown-unknown liner-unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.
Event or Problem Description
It was reported that patient experienced an intraoperative femoral calcar fracture that was stabilized with cerclage wires.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4) d11: 010000665-g7 pps ltd acet shell 56f-6594132.010000858-g7 neutral e1 liner 36mm f- 6551570.00877503603-bioloxâ® delta ceramic head-2989488.This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d11; g4; h2; h3; h6 reported event was confirmed by review of clinical records by a health care professional.Review of the available records identified an intraoperative calcar crack on right femur that was noted to be resolved with placement of prophylactic cerclage wire.There was no significant medical history, medications, or other factors that may have contributed to this event.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot 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
No additional information on reported event.

• Brand Name: FEMORAL STEM PRESS-FIT COLLARLESS 12/14 NECK TAPER
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9897911
• Report Number: 0001822565-2020-01132
• Device Sequence Number: 2437871
• Product Code: LPH
• UDI-Device Identifier: 00889024139251
• UDI-Public: (01)00889024139251
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K051491
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2020

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: 00786401300
• Device Lot Number: 63973036
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10; SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 82