MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR NECK R 12/14 NECK TAPER USE WITH +0 HEADS ONLY; PROSTHESIS, HIP

Model Number N/A

Device Problem Corroded (1131)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Non-union Bone Fracture (2369); Osteopenia/ Osteoporosis (2651)

Event Date 11/26/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00784802400, modular neck, 62622603.00625006525, bone screw, 62869681.00885101036, neutral liner, 62679968.00875705201, shell, 62831028.00877503602, ceramic head, 2769954.Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 01182.

Event Description

It was reported that patient underwent a right hip revision approximately 3.5 years post implantation due to patient developing nonunion & migration of the fracture site.Corrosion was noted on the neck.The stem, neck, liner, and head were removed and replaced.No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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 available records identified the following: the patient underwent an initial right total hip arthroplasty and during the initial procedure, intraoperative fracture of the greater trochanter occurred.Right periprosthetic displaced fracture nonunion of the greater trochanter around a well-fixed total hip arthroplasty.There is a history of nondisplaced greater trochanteric fracture had been treated nonoperatively, but continued to have significant pain and progressive superior migration.Elected to have revision to fix the trochanteric fracture.Chronic periprosthetic fracture nonunion of right greater trochanter, painful right total hip arthroplasty with abductor insufficiency 2nd to superior migration of greater trochanter.Greater trochanteric fracture extended distal and lateral, significant amount of lateral uncoverage of the femoral stem, noted little ingrowth of stem.Review of the device history records 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 Description

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

• Brand Name: MODULAR NECK R 12/14 NECK TAPER USE WITH +0 HEADS ONLY
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13101111
• MDR Text Key: 282955675
• Report Number: 0001822565-2021-03697
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2022

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: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 00784802400
• Device Lot Number: 62622603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/17/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 05/09/2022
• Supplement Dates FDA Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White