MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL POROUS WITH CLUSTER HOLES 48 MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Unintended Movement (3026)

Patient Problems Host-Tissue Reaction (1297); Local Reaction (2035); Tissue Damage (2104)

Event Date 11/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: 00801803203 versys head 60919187; 65771100700 stem 61418507; 00631004832 trilogy liner 61320625; 00625006535 bone screw 61436685.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 02841, 0002648920 - 2020 - 00316.Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Medical records identified the following: the patient had elevated metal ion levels.During the revision procedure, adverse local tissue reaction and scar tissue were identified.Black ring was observed on the trunnion.Anterior impingement at 45 degrees was noted during range of motion trials prior to dislocating the hip.The head and liner were replaced with new zimmer biomet products.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported patient underwent left hip revision approximately eight years post implantation due to elevated metal ions and altr.During the procedure, a pseudotumor was noted and excised, head and liner components were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: SHELL POROUS WITH CLUSTER HOLES 48 MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 10583277
• MDR Text Key: 208512958
• Report Number: 0001822565-2020-03300
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093561
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2010
• Device Model Number: N/A
• Device Catalogue Number: 00620204822
• Device Lot Number: 61505877
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2010
• 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
• Patient Outcome(s): Hospitalization; Required Intervention