MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 54F; PROSTHESIS, HIP

Model Number N/A

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

Patient Problem Cellulitis (1768)

Event Date 05/07/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 110024464 ¿ g7 dual mobility liner ¿ 080510.192112 ¿ echo femoral stem ¿ 089200.650-1158 ¿ delta ceramic head - 3034386.Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product remains implanted.The investigation is in process.Once the investigation is completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 01705.0001825034 - 2021 - 01706.

Event Description

It was reported that patient developed cellulitis approximately 3 days after an initial right total hip arthroplasty requiring medication.Approximately 2 weeks later the patient was seen for a follow up with improved symptoms and noted to continue medication for an additional 10 days.No surgical intervention will be conducted at this time.No additional information on the reported event is unavailable at this time.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

Cellulitis is common bacterial infection of the superficial skin that has the ability to spread quickly in the right conditions.Cellulitis appears as localized redness, swelling, is hot to touch and can be painful to touch.The bacteria enter the skin via any cut, abrasion or break in the skin, thus placing postoperative joint patients at increased risk for the development of cellulitis.Common pathogens that are associated with cellulitis are, streptococcus or mrsa (methicillin resistant staphylococcus aureus).Cellulitis may resolve on its own with little intervention or may require advanced treatment in more severe cases, such as administration of antibiotics and hospitalization; as reported this patient was diagnosed with cellulitis on postop day 3 and required treatment with antibiotics which would signify a deviation.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b5; g3; h2; h6 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

It was reported that patient developed cellulitis approximately 3 days after an initial right total hip arthroplasty requiring medication.Approximately 2 weeks later the patient was seen for a follow up with improved symptoms and noted to continue medication for an additional 10 days.The patient was noted to have resolved symptoms approximately 25 days after initial occurrence.No surgical intervention will be conducted at this time.No additional information on the reported event is unavailable at this time.

• Brand Name: G7 PPS LTD ACET SHELL 54F
• 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: 11932742
• MDR Text Key: 254264122
• Report Number: 0001825034-2021-01704
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• 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: 010000664
• Device Lot Number: 6870377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White