MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BI-METRIC/X POR NC LAT 16X160; PROSTHESIS, HIP

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problem Joint Dislocation (2374)

Event Date 12/27/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products.Concomitant medical products: unknown stem, biomet head cat#unk lot#883310, biomet cup cat#unk lot#543890, unknown liner.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 00354, 0001825034 - 2020 - 00355.

Event Description

It was reported the patient underwent a tha on an unknown date.Subsequently, the patient was revised due to head coming off the trunion and wear.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: b5, d1, d2, d4, d6, d11, g5, h2; h3; h4; h6 d11: biomet stem cat#x11-180316 lot#314710, biomet head cat#163663 lot#883310, biomet shell cat #13-104052 lot#543890.Reported event was confirmed with product return.Visual examination of the returned stem found the stem's taper to be heavily deformed due to wear.A large amount of material has been worn off.Scratching and foreign debris were found on the porous coating and distal portion of the stem.The neck of the stem is also heavily scratched.Visual examination of the returned head found the outer radius to be scuffed and scratched consistent with implantation and use.Scratching and scuffing were observed on the taper.Review of the device history records identified no deviations or anomalies during manufacturing.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

It was reported the patient underwent a tha.Subsequently, the patient was revised approximately 13 years later due to head coming off the trunion and wear.No further event information available at the time of this report.

• Brand Name: BI-METRIC/X POR NC LAT 16X160
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9615560
• MDR Text Key: 175833644
• Report Number: 0001825034-2020-00354
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K020580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Model Number: N/A
• Device Catalogue Number: X11-180316
• Device Lot Number: 314710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2020
• 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