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

Model Number N/A

Device Problems Material Erosion (1214); Metal Shedding Debris (1804)

Patient Problems Fall (1848); Pain (1994); Reaction (2414); Metal Related Pathology (4530)

Event Date 05/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2016-04191.Concomitant products: unknown m2a cup, catalog#: unknown, lot#: unknown.Unknown stem, catalog#: unknown, lot#: unknown.Report source: (b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Device history record 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.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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

Legal counsel for patient reported that patient underwent a right hip revision procedure approximately seven years post-implantation due to alleged misalignment of the hip, elevated metal ion levels, pseudotumors, tendon avulsion, hip pain due to metallic wear debris, metallosis, muscle weakness and mobility issues.Legal counsel reported that the patient's thigh muscle had also allegedly been irreparably damaged by metallic debris and needed to be removed and replaced by neighboring muscle.Legal counsel also reported that the patient experienced fall post revision surgery, due to muscle weakness.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

It was reported that the patient underwent an initial right total hip arthroplasty.Subsequently patient reported concerns with clicking/squeaking noise from hip.Metal ions were noted to be elevated.The patient underwent revision approximately 7 years post-implantation.The cup and head/neck were revised.Surgeon noted during the surgery, significant metallosis joint space and trunnions at the head/neck.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Mechanical (g04) - head.No product was returned; product evaluation could not be completed.Part and lot identification are necessary for review of device history records and complaint history, neither were provided.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues.Squeaking noise, no pain, cobalt, chromium both elevated, failed right tha, metallosis, trunnionosis.A 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 further information 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: 6986627
• MDR Text Key: 90530922
• Report Number: 0001825034-2017-09732
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2024
• 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 NARRATIVE. ; SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 104 KG