MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN STEM; PROSTHETIC, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problems Ossification (1428); Pain (1994); Local Reaction (2035); Tissue Damage (2104); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 12/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 04463.

Event Description

It was reported the patient underwent a hip revision 11 year after implantation due to corrosion at head neck junction.Head and liner were revised.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Supplied photo was enlarged and on the head you can see 072330, +9mm, b and blood obscures any other information.Also, a damaged liner with no visible information and a locking ring with no visible information can be seen.No product was returned; visual and dimensional evaluations could not be performed.Item# unk stem lot# unk- part and lot identification are necessary for review of device history records, neither were provided.Mmi review identified osteolysis, no acute fracture, dislocation, or frank implant loosening.A definitive root cause cannot be determined.X-ray review identified 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: UNKNOWN STEM
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11111086
• MDR Text Key: 225071694
• Report Number: 0001825034-2020-04464
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• 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
• Date Manufacturer Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ITEM#00630505636 NAME LINER STD 3.5 MM LOT#UNK
• Patient Outcome(s): Hospitalization; Required Intervention