MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER PLASMA; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Swelling (2091); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: cat# 00801803202 femoral head lot# 61450702.Cat# 00620005622 shell porous lot# 61381069.Cat# 00-6310-056-32 xlpe 10 deg poly liner lot# 60446737.Cat# 00-6250-065-30 trilogy bone scr lot# 61422326.The device will not be returned for analysis, as the device remains implanted; 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: 0002648920 - 2020 - 00451.

Event Description

It was reported patient¿s legal counsel reported patient underwent a right hip arthroplasty.Legal counsel further reports patient has not yet scheduled a surgery for explantation of the right hip components at issue.Patient is experiencing elevated metal ion levels and swelling.No additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The event was confirmed with medical records received.Review of the available records identified the following: the patient has been experiencing elevated metal ions and swelling.Patient's blood work confirmed elevated metal ion levels.A revision procedure is not yet scheduled.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: FEMORAL STEM 12/14 NECK TAPER PLASMA
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10655334
• MDR Text Key: 210600805
• Report Number: 0001822565-2020-03478
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K192660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

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: 12/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 00771101100
• Device Lot Number: 61375652
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 10/09/2020
• Supplement Dates Manufacturer Received: 02/08/2021
• Supplement Dates FDA Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Other
• Patient Weight: 91