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

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Bone Fracture(s) (1870); Blood Loss (2597)

Event Date 10/06/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: (b)(4), femoral head sterile product do not resterilize 12/14 taper, 62778846; (b)(4), liner elevated rim 36 mm i.D.Size ll for use with 58 mm o.D.Size ll shell, 63276424; (b)(4), shell with multi holes porous 58 mm o.D.Size ll for use with ll liners, 62700759.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient's right hip was revised two years post implantation due to injury while riding her bike that resulted in peri-prosthetic and implant fractures.During the revision, the patient experienced blood loss of 1100ml, with 625ml reinfused with cell saver.Attempts have been made and additional information on the reported event is unavailable.

Event Description

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

Manufacturer Narrative

Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2019-00588.Reported event was confirmed by review of operative notes.Operative notes state that the patient was revised due to proximal femur fracture and femoral stem fracture.Estimated blood loss 1100ml.The stem was fractured proximally in conjunction with a greater trochanteric/intertrochanteric hip fracture.There was apparently an intraoperative fracture during the previous revision and the long porous coated stem was placed in her femur and several cables were placed proximally.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.

• Brand Name: REVISION FEMORAL STEM BEADED FULLCOAT PLUS 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: 8439390
• MDR Text Key: 139423228
• Report Number: 0001822565-2019-01137
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K953337
• 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: 08/06/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 00784301108
• Device Lot Number: 62522383
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2019
• Initial Date FDA Received: 03/21/2019
• Supplement Dates Manufacturer Received: 07/24/2019
• Supplement Dates FDA Received: 08/07/2019
• 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 Age: 45 YR