MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ZIMMER M/L TAPER STEM; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems No Information (3190); Metal Related Pathology (4530)

Event Date 05/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Item #: unknown liner lot #: unknown.Item #: unknown cup lot #: unknown.Item #: 008018003202, versys femoral head lot #: 60597524.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product remains implanted.The investigation is in process.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: 0002648920-2020-00289.

Event Description

It was reported the patient underwent a left tha.The patient was revised over fourteen years later due to elevated ions.Her cobalt level is currently as high as its ever been.Head was removed and staining was seen on the neck.There was also black staining inside the femoral head.The liner was also removed and was damaged upon removal.A new trilogy liner and biolox head were re-implanted.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, g4, h2, h3, h6.Reported event was confirmed by review of radiographs, photos and examination of returned head.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.Radiographs indicate metallosis, corrosion, and associated findings would be better represented on ct or mri.Black staining on implants confirmed in intraop pictures provided in the complaint.If any further information is found which would change or alter any conclusions or information, a supplemental report 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: 00630505032- liner standard 32 mm i.D.For use with 50/52/54 mm o.D.Shells- unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent a left hip revision approximately 14 years post implantation due to elevated metal ions.During the revision adverse local tissue reaction, corrosion, and osteolysis were discovered.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Reported event was confirmed via medical records that were provided and reviewed by a health care professional.Review of the available records identified the following: a revision occurred due to elevated metal ions.Corrosion was found at the base of the head, and altr within the joint.Osteolysis was found in the femur.The shell was stable, and the neck was cleaned of debris.A new zimmer liner and head was placed with no complications.Root cause unchanged.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 information on the reported event.

• Brand Name: UNKNOWN ZIMMER M/L TAPER STEM
• 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: 10106354
• MDR Text Key: 194193475
• Report Number: 0001822565-2020-01972
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: SEE H10.; SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 77 KG