MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 44MM I.D. SIZE I +5MM OFFSET LINER; PROSTHESIS, HIP

Model Number N/A

Device Problems Off-Label Use (1494); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 11/24/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00625006530-bone screw self-tapping 6.5 mm dia.30 mm length-j6979290, 00625006520-bone screw self-tapping 6.5 mm dia.20 mm length-j6864845.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2022 - 00716 and 0001822565 - 2022 - 00717.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product location unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent a left hip revision approximately 2 months¿ post implantation due to implant loosening.During the procedure all implants were removed including a 44 ringloc bipolar with a 44 +5 liner which were off-label use, surgeon was aware.The patient now only has cement in the hip area.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.Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was submitted in error and should be voided.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

Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was submitted in error and should be voided.

• Brand Name: 44MM I.D. SIZE I +5MM OFFSET LINER
• 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: 13769717
• MDR Text Key: 287186492
• Report Number: 0001822565-2022-00715
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024520899
• UDI-Public: (01)00889024520899(17)250531(10)64768030
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 06/27/2022

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 Model Number: N/A
• Device Catalogue Number: 30154409
• Device Lot Number: 64768030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2022
• Supplement Dates Manufacturer Received: 06/20/2022
• Supplement Dates FDA Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female