MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM I.D. SIZE E NEUTRAL LINER; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930)

Event Date 03/23/2022

Event Type  Injury  

Event Description

It was reported that patient underwent a left hip revision approximately 15 days post implantation due to infection.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).110010244 ¿ g7 shell ¿ 65273275, 574101050 ¿ femoral stem ¿ 3066872, 00877503602 ¿ biolox ceramic head ¿ 3090857, 00625006535 ¿ bone screw - j7149850.Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product location is unknown.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: 0001822565 -2022 -01637, 0001822565 - 2022 -01638.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were {updated/corrected}.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, therefore implanted products are not identified as the source or contributing to the reported infection.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: 36MM I.D. SIZE E NEUTRAL LINER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14550582
• MDR Text Key: 293003680
• Report Number: 0001822565-2022-01636
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024519909
• UDI-Public: (01)00889024519909(17)270106(10)65256641
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/12/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 30103605
• Device Lot Number: 65256641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/04/2022
• Initial Date FDA Received: 05/31/2022
• Supplement Dates Manufacturer Received: 07/06/2022
• Supplement Dates FDA Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2022
• 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: SEE H10
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female