MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN HEAD; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Unintended Movement (3026); Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544); No Information (3190); Metal Related Pathology (4530)

Event Date 05/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: item #: unknown, unknown stem lot #: unknown; item #: unknown, unknown liner lot #: unknown; item #: unknown, unknown cup lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 00268.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

Patient's legal counsel reported patient underwent a right hip arthroplasty and was revised seven years later for unknown reasons.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.   medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient underwent a revision due to metallosis and corrosion, while also experiencing pain a month before revision and unable to bear weight due to a trauma on may 4, 2018.X-ray showed that there was a disassociation of the head from the neck, and metal ions were elevated, with a cobalt level of 1.7mcg/l and a chromium level of 4.1mcg/l.No evidence of infection noted, but found thick black fluid within the hip joint.During the revision it was found the poly liner was damaged, there was a crack on the acetabulum, and corrosion and metallosis was found as well.The stem, head, and liner were revised and new zimmer products put in place.Rom was tested and deemed acceptable prior to closure.The root cause remains 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

It was reported by the patient's legal counsel, patient underwent a right hip arthroplasty.The patient was revised 7 years post implantation due to metallosis and corrosion.The patient began to experience groin pain approximately one month prior to revision and with trauma was unable to bear weight.It was discovered on x-ray there was a disassociation of the femoral head from the neck, and his metal ions were elevated.During revision a linear crack along the rim of the acetabulum was noted as well as a damaged poly liner, corrosion and metallosis.The stem, head and liner were revised.During removal of the stem, an osteotomy was performed as the stem was well integrated, and a fracture occurred and was secured prior to closure.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.

Event Description

No further event information available at the time of this report.

• Brand Name: UNKNOWN HEAD
• 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: 11279475
• MDR Text Key: 230287854
• Report Number: 0001822565-2021-00267
• Device Sequence Number: 1
• Product Code: KWA
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• 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: 01/13/2022
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male