MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK STEM; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Patient Device Interaction Problem (4001)

Patient Problem Metal Related Pathology (4530)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Https://doi.Org/10.1016/j.Arth.2021.11.026.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 01415.

Event Description

It was reported a journal article was retrieved from the journal of arthroplasty (2022) that reported a study from the united states that looked at the 10 year follow up results in total hip arthroplasties (tha) performed at maine medical center by dr.Brian mcgrory.The purpose of the study was to determine the incidence of serum co levels of >1 ppb in a cohort of these contemporary, non-recalled implants that have been shown to have a high prevalence of revision for symptomatic mechanically assisted crevice corrosion (macc).The study reviewed 162 patients that underwent primary total hip arthroplasty with zimmer implants.After exclusion criteria and lost to follow up, 109 patients were included in the final results.Implants included a cobalt chrome head, a poly liner, a non-cemented acetabulum (trilogy in 78 hips and trilogy tm in 84 hips), and a femoral stem (m/l taper in 148 hips, fiber-metal taper in 9 hips, an m/l taper with kinectiv technology in 3 hips, and an epoch stem in 2 hips).The study population had a mean age of 60.1 years at time of surgery (range 47-91 years).The study reported one patient was revised due to implant corrosion, adverse local tissue reaction, and elevated metal ion levels.Attempts have been made and no further information has been provided.

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.H6: component code: mechanical (g04) - stem.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: UNK STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14700603
• MDR Text Key: 294125532
• Report Number: 0001825034-2022-01416
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNK COCR HEAD
• Patient Outcome(s): Hospitalization; Required Intervention