MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS; PROSTHESIS HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214)

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

Event Date 12/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: part # 00801803201/ femoral head sterile / lot # 60975936.Part # 00620005622/ shell porous with cluster holes / lot # 61660755.Part # 00630505632/ liner / lot # 61604354.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 00915.

Event Description

It was reported that the patient underwent a right hip arthroplasty.Subsequently, patient underwent revision surgery due to pain and elevated metal ion levels.During surgery the surgeon noted a slight ring of necrotic bone along the proximal femur at the level of the prosthesis, femur junction.Surgeon further encountered marked blackening of the trunnion going below the femoral head posteriorly.Flakes of blackened material were evident in the joint.After removing the versys femoral head, the surgeon found significant goldberg grade iv discoloration of the trunnion and bore of the femoral head consistent with corrosion and/or fretting.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

It was reported that patient underwent hip revision surgery 11 years post implantation due to pain, elevated metal ions, and effusion.During the revision corrosion was noted on the head and neck trunnion.Pathology reports revealed alval on the psuedocapsule specimen, the head and liner were replaced without complication.Attempts have been made and additional information is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the chromium level was at a 1.8 when the normal level is <0.3 and the cobalt level was 6.5 when it is normally <1.0.A slight ring of necrotic bone was found at the prosthesis femur junction and the patient presented with pain.The joint fluid was normal but more abundant, which is consistent with effusion.There was marked blackening of the trunnion consistent with corrosion.The acetabular component was discolored, which is consistent with wear and oxidation.The pseudocapsule was sent to pathology and alval was present, with no acute inflammation seen.The initial shell and stem was well fixed and retained, the head and liner were replaced without complication.Device history record (dhr) was reviewed and no discrepancies were found.Root cause of the event could not 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: a4; b7; g3; h2.

Event Description

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

• Brand Name: FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11602974
• MDR Text Key: 243517743
• Report Number: 0001822565-2021-00929
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 00889024131743
• UDI-Public: (01)00889024131743(17)210131(10)61690517
• Combination Product (y/n): N
• PMA/PMN Number: K192660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 00771100900
• Device Lot Number: 60921281
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 73