MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER CEMENTLESS SIZE 9 STANDARD OFFSET; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Necrosis (1971); Pain (1994); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Swelling/ Edema (4577)

Event Date 08/06/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2021 - 00230.

Event Description

It was reported that the patient underwent a left hip arthroplasty.Subsequently, the patient was revised approximately 4 years later.The doctor said he recalled unexplained pain so he did a blood test which resulted in 'negative ion test' so resulted in a head revision where they swapped out to a biolox option head.Fluid was murky appearing and trunion did have signs of metallosis but not affected enough to revise stem.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, g3, h2, h3, h6.Reported event was confirmed by review of medical records.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Medical records identified the following: increasing pain and swelling.Sed rate and c-reactive protein normal, elevated cobalt and chrome levels.Mri demonstrated fluid inside the hip.Cloudy fluid noted in hip joint sent for cultures and frozen section ¿ no sign of infection.Black debris inside the head and around the trunnion, (trunnionosis).Trunnion cleaned and remained intact.Fluid was murky appearing and grunion did have signs of metallosis but not affected enough to revise stem.If any further information is found which would change or alter any conclusions or information, a supplemental report 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.

Event Description

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

Manufacturer Narrative

Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b6; b7; d1; d2; d4; d10; g4; h2; h4; h6.D10: ref 5360-00-051 lot62654321 shell.Ref 4377-32-051 lot 62588830 acetabular insert.Ref 00-6250-065-20 lot 62717058 bone screw.Ref 00-6250-065-25 lot 62748071 bone screw x 2.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Additional medical records were provided and identified increasing discomfort in left hip and buttock, pain with weight-bearing.X-ray identified no evidence of loosening, increasing radiolucencies to the grater trochanter.Adverse local soft tissue reaction with synovitis.Erosive changes at left greater trochanter and non-specific reactive marrow signal change/marrow edema in left greater trochanter.Pathology report identified necrotic tissue and ample chronic inflammation of synovia, rate tissue fragments with increased neutrophils.Clinical notes identified discomfort deep in the joint, pain 1-2/10, no pain meds.Chromium normal, cobalt still pending.Review of the device history records identified no related deviations or anomalies during manufacturing.Additional information does not change the root cause of previous investigation.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: FEMORAL STEM 12/14 NECK TAPER CEMENTLESS SIZE 9 STANDARD OFFSET
• 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: 12383426
• MDR Text Key: 268648537
• Report Number: 0001822565-2021-02390
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192660
• 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,Followup,Followup,Followup
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 65771100900
• Device Lot Number: 62509324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2013
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male