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

Catalog Number 65771100900

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Pain (1994); Synovitis (2094); Metal Related Pathology (4530)

Event Date 08/11/2021

Event Type  Injury  

Event Description

It was reported that the patient underwent a left hip revision approximately 11 years post implantation due to pain, elevated ions and metallosis.Due the procedure, black synovitis was noted throughout the joint.The acetabular and head were removed and replaced.It was reported that no further information is available.

Manufacturer Narrative

(b)(4).Concomitant medical products: cat #: 01.00181.440, metasul large diameter hd 44/j, lot #: 2424373, cat #: 01.00185.145 / head adapter s/-4 12/14-18/20 / lot #: 2502406, unknown acetabular.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated.H6: component code: mechanical (g04) - stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left tha was performed on (b)(6) 2010.A revision occurred on (b)(6) 2021 due to pain, elevated metal ions, and metallosis.Black synovitis was noted throughout the joint.The pseudocapsule was noted to be intact, and the femur component well fixed.No complications were noted, and new zimmer products were placed.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

There is no update to the complaint description provided.

Event Description

There is no update to the original complaint description provided.

Manufacturer Narrative

Supplemental report provided as additional information was received with patient information(b7) and lab values (b6).In addition, review of x-ray found acetabular component proud to the anterior acetabulum.Additional medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the shell was identified to be a durom component, and it was noted on x-ray at an office visit on (b)(6) 2021 that the acetabular component was proud to the anterior acetabulum.No further information was 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.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED
• 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: 15649495
• MDR Text Key: 302165848
• Report Number: 0001822565-2022-03009
• Device Sequence Number: 1
• Product Code: LZO
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2023

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: 01/31/2020
• Device Catalogue Number: 65771100900
• Device Lot Number: 61371599
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2022
• Initial Date FDA Received: 10/21/2022
• Supplement Dates Manufacturer Received: 10/31/2022; 02/03/2023
• Supplement Dates FDA Received: 11/04/2022; 02/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 76 KG