MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR FEMORAL STEM PRESS-FIT; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Fall (1848); Bone Fracture(s) (1870); Scar Tissue (2060); Tissue Damage (2104)
Date of Event	08/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: zimmer biolox⮠delta, ceramic femoral head, m, 㸠32/0, taper 12/14 cat#00877503202 lot#3011774.Zimmer modular neck b 12/14 neck taper use with +0 heads only cat#00784802200 lot#64561290.Zimmer shell porous with cluster holes 54 mm cat#00620205422 lot#64333649.Zimmer liner standard 32 mm i.D.For use with 50/52/54 mm o.D.Shells cat#00630505032 lot$64489628.Zimmer bone scr 6.5x30 self-tap cat#00625006530 lot#64611740.Zimmer bone scr 6.5x30 self-tap cat#00625006530 lot#64613278.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device being discarded.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 that a patient underwent a right tha.Subsequently, the patient fell approximately 2 months later sustaining a femoral periprosthetic fracture.The patient underwent an orif and revision 3 days after the fall.The stem, neck, and head were removed and replaced.It was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Medical records and radiographs were provided and reviewed by a health care professional.Review of the available records identified the following : the patient fell and sustained a femoral periprosthetic fracture.Patient underwent an orif and revision.The orif procedure was completed with zimmer 2.0 cables.Cable placed distal to lesser trochanter.Additional cable to get the smaller more distal fragment 3rd cable passed through drill hole of lesser trochanter to prevent migration.The head and stem were replaced with wagner revision stem and a biolox head.The new stem sat slightly more proud than the trial (by a few mm).No other findings/complications related to the event were noted.Review of the device history records identified no deviations or anomalies during manufacturing.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 further event information available at the time of this report.

• Brand Name: MODULAR FEMORAL STEM PRESS-FIT
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10519061
• Report Number: 0001822565-2020-03204
• Device Sequence Number: 16944803
• Product Code: LPH
• UDI-Device Identifier: 00889024132658
• UDI-Public: (01)00889024132658(17)300131(10)64524364
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K182678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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: 00771301200
• Device Lot Number: 64524364
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 12/16/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 76