MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM BASE PLATES AND HUMERAL STEMS; EXTREMITY IMPLANT

Model Number N/A

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

Patient Problem Ossification (1428)

Event Date 09/13/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: concomitant medical product: catalog #: unknown, humeral tray, lot # unknown.G2: australia.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by hospital.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: 0001822565-2023-02716.

Event Description

It was reported patient underwent a shoulder arthroplasty approximately 3 years ago.Subsequently the patient required removal of the glenoid and humeral tray in order to remove sufficient amounts of heterotopic ossification of the joint capsule.Attempts have been made and there is no further information at this time.

Manufacturer Narrative

(b)(4).Reported event was confirmed as heterotopic ossification (ho) is the abnormal and rapid growth of bone that forms within soft tissue as the result of heredity, trauma, surgical history, or diseases of a joint.The rapid and irregular growth of bone often causes a sharp or jutted structure to form, which can result in pain and irritation to the surrounding tissues, or the patient can remain asymptomatic.Radiation or nonsteroidal anti-inflammatory medications are often provided to prevent ho formation.The only treatment, if necessary, is surgical excision or shaving/smoothing out the excess bone.As timeframes of onset differ due to individual contributing factors, a specific timeframe of expected occurrence cannot be established.A definitive root cause could not be determined.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: ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM BASE PLATES AND HUMERAL STEMS
• Type of Device: EXTREMITY IMPLANT
• 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: 17894361
• MDR Text Key: 325240017
• Report Number: 0001822565-2023-02711
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00889024269163
• UDI-Public: (01)00889024269163(17)251231(10)63229515
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K121543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• 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: 00434904011
• Device Lot Number: 63229515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2015
• 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: 67 YR
• Patient Sex: Male