MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL HEAD 45X16; PROSTHESIS, SHOULDER, SEMI CONSTRAINED, METAL/POLYMER, UNCEMENTED/EXTREMITIES

Catalog Number SAHH4516

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Hematoma (1884); Pain (1994); Fluid Discharge (2686); Subluxation (4525)

Event Date 10/09/2023

Event Type  Injury  

Manufacturer Narrative

Cmp-(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-00498, 0001822565-2024-00500, 0001822565-2024-00501, 0001822565-2024-00502.D10: medical products: item#: sagl2024, 3 peg mono glen sz 4; lot#: 65268604.Item#: sahs1111, humeral stem standard size 11; lot#: 65628117.Item#: sahha001, hum head adapter identity; lot#: 66023931.Item#: sahaf135, hum stem adapter 135 deg; lot#: 66074660.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial total shoulder arthroplasty approximately four (4) and a half months ago.Subsequently, the patient was seen approximately two (2) and a half weeks after the surgery and was complaining of wound drainage and increased pain following a sudden grab of their pants as they were falling down a few days prior to the appointment.On evaluation a hematoma was present, and the patient was prescribed antibiotics.It was noted on x-ray that there was evidence of the implants subluxing.At the patient's six weeks appointment the hematoma had resolved, and the patient reported no further complications.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-00498-1, 0001822565-2024-00500-1, 0001822565-2024-00501-1, 0001822565-2024-00502-1.A hematoma is a mass of clotted blood that forms in a tissue, organ, or body space.A hematoma can be associated with pain, swelling, ecchymosis, serosanguinous or bloody drainage after a recent surgical procedure or trauma and can predispose the patient to infection.The development of a postoperative hematoma can be correlated with the surgical procedure and perioperative anticoagulation therapy prescribed to prevent thrombus formation.Most hematomas resolve on their own, without surgical intervention, while some do not.Larger hematomas may need to be surgically evacuated in order to resolve.As timeframes of onset differ due to individual contributing factors, a specific timeframe of expected occurrence cannot be established.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: HUMERAL HEAD 45X16
• Type of Device: PROSTHESIS, SHOULDER, SEMI CONSTRAINED, METAL/POLYMER, UNCEMENTED/EXTREMITIES
• 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: 18699082
• MDR Text Key: 335293514
• Report Number: 0001822565-2024-00499
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213856
• 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
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SAHH4516
• Device Lot Number: 65488726
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 128 KG