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

Model Number	N/A
Medical Device Problem Codes	Corroded (1131); Material Erosion (1214)
Health Effect - Clinical Codes	Necrosis (1971); Pain (1994); Metal Related Pathology (4530); Swelling/ Edema (4577)
Date of Event	12/12/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Additional 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 or Problem Description
No further event information available at the time of this report.
Additional 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 or Problem 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
• Common Device Name: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11602974
• Report Number: 0001822565-2021-00929
• Device Sequence Number: 3622514
• Product Code: MEH
• UDI-Device Identifier: 00889024131743
• UDI-Public: (01)00889024131743(17)210131(10)61690517
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K192660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,health p
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/29/2021

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 04/26/2021; 08/10/2021; 09/20/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 05/11/2021; 08/18/2021; 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 73