MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 28MM DIA COCR MOD HD -6MM NK; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Pain (1994); Visual Disturbances (2140); Hip Fracture (2349); Reaction (2414)

Event Date 11/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog number:x180307 lot number:773480 brand name: bimetric stem , catalog number:11-106048 lot number:174800 brand name: acetabular shell, catalog number: xl-105902 lot number:291570 brand name: arcom xl liner.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-04111.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient was revised due to elevated metal ion levels, metallosis, grown pain, leg length discrepancy, and pelvic fracture approximately 10 years post implantation.Additional information on the reported event is unavailable.

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.The reported event was able to be confirmed by evaluation of the suspected device and review of medical records.Visual inspection of the returned head showed discoloration to the outside radius with black material on the taper lip and inside of the taper.Medical records were provided and identified that the patient underwent a revision due to failed right hip arthroplasty secondary to metallosis.Cobalt and chromium levels were elevated at 14.5 and 6.0, respectively, consistent with metallosis.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause was not able to 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.

• Brand Name: 28MM DIA COCR MOD HD -6MM NK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9013662
• MDR Text Key: 158110552
• Report Number: 0001825034-2019-04112
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K911684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

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 Expiration Date: 05/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 163660
• Device Lot Number: 000610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/15/2019
• Initial Date FDA Received: 09/12/2019
• Supplement Dates Manufacturer Received: 01/22/2020
• Supplement Dates FDA Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 53