MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3 PEG MONO GLEN SZ 3; EXTREMITIES IMPLANTS

Model Number N/A

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

Patient Problems Hematoma (1884); Impaired Healing (2378)

Event Date 03/10/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - medical product: catalog #: 01.04555.440, humeral head 44-16, lot # 3088896.Catalog #: 01.04555.130, humeral anchor uncemented l, lot # 3080781.Catalog #: unknown, palacos cement, lot # unknown.Reported event was confirmed as from the medical records which stated that the patient had a hematoma.A hematoma is a mass of clotted blood that forms in a tissue, organ, or body space.Wound complications can be treated conservatively or more invasively with an irrigation and debridement (i&d) which promotes healing at the site and prevents further complications.Device history record (dhr) review was not reviewed as the root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device.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.H3 other text : remains implanted.

Event Description

It was reported a patient underwent a left anatomical total shoulder arthroplasty approximately 4 months ago.Subsequently, since surgery, the patient has experienced erythema around the surgical site and drainage from the wound.During an office appointment, 2 weeks later, an ultrasound guided needle aspiration was completed to rule out infection and diagnosed with complications of a post-operative hematoma.The patient was prescribed cephalexin after aspiration and culture results, resulted in no growth.The patient¿s wife reported the patient was rubbing and picking at the site.The patient continued oral antibiotics for two weeks and the surgical site and hematoma were considered resolved about a month later and has continued with no complications and remains very satisfied.

• Brand Name: 3 PEG MONO GLEN SZ 3
• Type of Device: EXTREMITIES IMPLANTS
• 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: 17278616
• MDR Text Key: 318580350
• Report Number: 0001822565-2023-01732
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2023

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: SAGL2023
• Device Lot Number: 64435172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2019
• 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 Sex: Male
• Patient Weight: 93 KG