MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM PRESS-FIT COLLARLESS 12/14TAPER EXTENDED NECK OFFSET SIZE 12 128 MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: g7 acetabular shell pn: 010000662 ln: 6522380, g7 acetabular liner pn: 010000856 ln: 6598669, ceramic femoral head pn: 00877503602 ln: 3002562.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.  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 the patient underwent a right total hip arthroplalsty.At the one month post-op visit it was noted the patient had a fractured femur and stem subsidence.No intervention is noted, just observation.Attempts were made to obtain additional information; however, none was available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, g4, h1, h2, h3, h6, h10.Correction: a1.Complaint sample was evaluated and the reported event was confirmed.Reported event was confirmed by review of medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient underwent a right tha, and a prophylactic cable was placed around the femur due to osteoporosis,no other complications were noted.At a post-op visit a month later, femur fracture and mild subsidence of the stem were noted, mild pain was also reported.Patient is under observation, no treatment yet.Device history record (dhr) was reviewed and no discrepancies 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: FEMORAL STEM PRESS-FIT COLLARLESS 12/14TAPER EXTENDED NECK OFFSET SIZE 12 128 MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9646388
• Report Number: 0001822565-2020-00398
• Device Sequence Number: 3445255
• Product Code: LPH
• UDI-Device Identifier: 00889024139244
• UDI-Public: (01)00889024139244
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00786401220
• Device Lot Number: 64180643
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 02/05/2020
• 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: 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 Weight: 54