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

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

Patient Problems Host-Tissue Reaction (1297); Ossification (1428); Pain (1994); Numbness (2415); Limited Mobility Of The Implanted Joint (2671)

Event Date 08/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.Reported event was unable to be confirmed due to limited information received from 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 is 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends item #unknown/ unknown head/ lot # unknown.Item # unknown/unknown stem/ lot # unknown.Item # unknown/unknown liner/ lot # unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2020 -00995; 0001822565 -2020 -00996.

Event Description

It was reported the patient underwent right hip revision surgery 2 years post implantation due to pain and elevated metal ion levels.It was indicated during the revision procedure, there was evidence of metallosis and corrosion.The acetabular components were noted to have minimal wear; therefore, they were retained.Further noted, post revision improvement in overall cobalt levels and adls.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: UNKNOWN CUP
• 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: 9917797
• MDR Text Key: 186234626
• Report Number: 0001822565-2020-01202
• Device Sequence Number: 1
• Product Code: JDI
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2020
• Initial Date FDA Received: 04/02/2020
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention