MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD NITROGEN; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Discolored (1170); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Local Reaction (2035)

Event Date 09/15/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign: country: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001822565 - 2022 - 00865.

Event Description

It was reported the patient underwent a hip revision approximately 7 years post implantation due to pain and a confirmed pseudo-tumor.There was some black discoloration on the inside of the head and on the trunnion of the neck.No additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D6a: implanted (b)(6) 2014.H6: component code mechanical (g04): head.Visual examination of the returned product identified the conical taper of both devices to exhibit dark debris.The eliliptical taper of the neck shows damage in the form of burnishing and gouges.Damage is also seen between the conical and elliptical tapers.Additionally, the head and neck were sent to sem analysis.The tapers of the returned devices were reviewed via optical microscopy.Both tapers were assigned the consensus modified goldberg score of 4 corresponding to the surface with a severe corrosion attack and abundant corrosion debris.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.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

No additional event information to report at this time.

• Brand Name: FEMORAL HEAD NITROGEN
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13939576
• MDR Text Key: 288169184
• Report Number: 0002648920-2022-00065
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K892800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 32801802802
• Device Lot Number: 62491250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2013
• 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# 00784801301 LOT# 62253439 NECK
• Patient Outcome(s): Hospitalization; Required Intervention