MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN M/L TAPER SIZE 15 STEM WITH A STANDARD OFFSET; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Loss of Range of Motion (2032); Burning Sensation (2146)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unk-unk 36mm+0 cocr head-unk, unk-unk 52mm longevity polyethylene liner-unk, unk-unknown cup-unk.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 01080, 0001822565 - 2020 - 01081, 0001822565 - 2020 - 01082.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.

Event Description

It was reported the patient is experiencing signs of elevated cobalt levels, cardiac issues, problems with balance, sleep disorder worsened, and constant coldness/numbness in feet, hands along with decline in ability to hear approximately 5 years post implantation.These issues have remained up to 7 years post implantation.No report of revision at this time.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.The following sections were updated/corrected updated: g4; h2; h3; h6 reported event was unable to be confirmed due to limited information received from the customer.No product was returned; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Complaint history review cannot be performed without product identification.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 information on reported event at this time.

• Brand Name: UNKNOWN M/L TAPER SIZE 15 STEM WITH A STANDARD OFFSET
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9882704
• MDR Text Key: 186267788
• Report Number: 0001822565-2020-01079
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 04/02/2020

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
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/04/2020
• Initial Date FDA Received: 03/26/2020
• Supplement Dates Manufacturer Received: 03/31/2020
• Supplement Dates FDA Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Other