MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC POR LAT FMRL 6.0X132; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Pain (1994); Local Reaction (2035); Tissue Damage (2104); Joint Dislocation (2374)

Event Date 09/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 04808, 0001825034-2019-04807.

Event Description

It was reported a patient had a right tha.Subsequently, the patient had suffered a dislocation and went to the er where she underwent a closed reduction approximately 11 years later.Approximately 2 months later, patient underwent a revision due to dislocation where the head was removed and replaced.Surgeon noted mild elevated metal ions, tissue damage and wear of the trunnion.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: d4; h2; h3; h4; h6.Reported event was confirmed with medical records and radiographs provided.Review of the available records identified the following: patient experienced a dislocation and underwent closed reduction in the er mild elevation of chromium & cobalt levels fluid tinged w/slight metal color trunnion did have some mild wear debrided synovitis or metallosed tissue 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

No further event information available at the time of this report.

• Brand Name: TAPERLOC POR LAT FMRL 6.0X132
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9512679
• MDR Text Key: 173069481
• Report Number: 0001825034-2019-05731
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K030055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

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: 03/28/2017
• Device Model Number: N/A
• Device Catalogue Number: 11-103201
• Device Lot Number: 461740
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 01/29/2020
• Supplement Dates FDA Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: BIOMET MAGNUM MOD HD CAT#S031140LOT#239670.; M2A-MAGNUM PF CUP 46ODX40ID.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 73