MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 12.5 STAN; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Necrosis (1971); Pain (1994); Scar Tissue (2060); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 01/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign: country: canada.(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.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.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2022 - 02757.

Event Description

It was reported that the patient underwent a right hip revision procedure approximately 4 years post-implantation.The patient has experienced pain and discomfort in relation to the implantation of the product.Prior to the revision surgery, the patient underwent diagnostic testing of her blood chemistry; analysis conducted indicated that the patient had sustained high levels of chromium and cobalt concentrate.As a result, the patient has sustained and will sustain serious injuries to their body, the particulars of which include, but are not limited to the following: metallosis, tissue dehiscence, tissue necrosis, bone necrosis, hypertrophic scarring, antalgia, lumbar strain, chronic pain and severe emotional and/or psychological distress relating to the pain and suffering associated with the defective product.No additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2023-00030.Proposed component code: mechanical (g04)- stem.Review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right tha was performed with no complications noted.A revision occurred approximately four(4) years later due to elevated metal ions, pain, and swelling.While in the joint, a pseudotumor was noted as well as black residue consistent with trunnionosis on the trunnion of the stem and inside the femoral head.The liner and head were removed and replaced with zimmer products with no complication noted.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

Initial right hip arthroplasty that was subsequently revised approximately four (4) years later due to metal-on-metal right total hip.During the revision metal on poly articulation was noted as well as periarticular pseudotumor and black debris.The femoral head and acetabular liner were explanted all other components remained.No intraoperative complications reported.

Event Description

No further information at the time of this report.

Manufacturer Narrative

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

• Brand Name: FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 12.5 STAN
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15485536
• MDR Text Key: 300579032
• Report Number: 0001822565-2022-02758
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00889024131866
• UDI-Public: (01)00889024131866(17)211231(10)61945467
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K200823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2024

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: 12/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 00771101200
• Device Lot Number: 61945467
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/26/2022
• Supplement Dates Manufacturer Received: 02/03/2023; 02/29/2024
• Supplement Dates FDA Received: 03/01/2023; 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2011
• 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: UNK CUP.; UNK HEAD.; UNK LINER.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 122 KG