MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEM STEM 12/14 NECK TAPER CEMENTLESS SIZE 15 EXTOFFSET; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Unstable (1667)

Patient Problem Metal Related Pathology (4530)

Event Date 07/30/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).D.O.B.: (b)(6) 1955 or 1965.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 has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2021-00312, 0001822565-2021-02870.

Event Description

It was reported that the patient underwent a revision procedure of the left hip approximately 7 years post implantation due to instability, metallosis and elevated metal ions.During the revision black fluid, corrosion noted to the trunnion, acetabular locking ring was damaged and caused damage to the acetabulum when removing the liner.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: b4, b5, d1, d2, d4, d10, g3, g4, g6, h2, h4, h10.

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 event was confirmed with medical records received.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified elevated cobalt ion levels.The records identified feelings of instability, black fluid noted and corrosion encountered.Femoral head removed and black corrosion noted at trunnion.Acetabular locking mechanism damaged, possible from a subluxation event, locking mechanism damage therefore caused damage to the cup when removing the liner.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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.

• Brand Name: FEM STEM 12/14 NECK TAPER CEMENTLESS SIZE 15 EXTOFFSET
• 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: 12589334
• MDR Text Key: 275135100
• Report Number: 0001822565-2021-02868
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 65771101520
• Device Lot Number: 62423221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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
• Treatment: CAT#: 00625006540 BONE SCREW LOT#: NI.; CAT#: 00630505036 ZIMMER LINER LOT#: 62672803.; CAT#: 00801803602 FEMORAL HEAD LOT#: 62709434.; CAT#: 65771101520 FEMORAL STEM LOT#: 62423221.; CAT#:00620205222 ZIMMER SHELL LOT#: 62108372.; CAT#: 00630505036 ZIMMER LINER LOT#: 62672803; CAT#: 00801803602 FEMORAL HEAD LOT#: 62709434; CAT#:00620205222 ZIMMER SHELL LOT#: 62108372
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male