MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Hematoma (1884); Osteopenia/ Osteoporosis (2651)

Event Date 07/03/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: zimmer liner standard 28 mm i.D.For use with 50/52/54 mm o.D.Shells cat# 00630505028 lot# 60300867.Zimmer femoral head sterile product do not resterilize 12/14 taper cat# 00801802801 lot# 60294109.Zimmer shell porous with cluster holes 50 mm o.D.Cat# 00620005022 lot# 60294926.Zimmer bone scr 6.5x20 self-tap cat# 00625006520 lot# 60310179.Zimmer bone scr 6.5x30 self-tap cat# 00625006530 lot# 60310192.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 Description

It was reported the patient underwent primary left tha.Subsequently, patient sustained periprosthetic bone fracture of femur and underwent revision of left tha approximately 15 years later.All components explanted except for shell, and cable plate system was used to stabilize femur fractures.Surgeon noted patient had poor bone quality and thin bone at the location of bone fracture.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: g4; h2; h3; h6 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the records identified the following: the patient underwent a revision procedure due to periprosthetic fracture.The lesser trochanter was fractured, very thin bone near the greater trochanter, large fragment extending from greater trochanteric down to distal extent laterally on cortex of the femur.A hematoma, likely due to the fracture, was evacuated.The shell was notably well fixed, the liner, head and stem were removed.The distal femur was cabled to prevent further propagation of the fracture.New stem was placed without trialing due to poor quality bone.Constrained liner was implanted due to noted instability during rom trial.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.No corrective actions, preventive actions, or field actions resulted after investigation of this event.

Event Description

No further event information available at the time of this report.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10367604
• MDR Text Key: 201697099
• Report Number: 0001822565-2020-02783
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K192660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 10/07/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Model Number: N/A
• Device Catalogue Number: 00771101100
• Device Lot Number: 60281003
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/11/2020
• Initial Date FDA Received: 08/05/2020
• Supplement Dates Manufacturer Received: 10/07/2020
• Supplement Dates FDA Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 88