MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OFFSET MODULAR HUMERAL HEAD 19 MM HEAD HEIGHT 46 MM SPHERICAL HEAD DIAMETER; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED/EXTREMITIES

Catalog Number 00430204619

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

Patient Problems Osteolysis (2377); Osteopenia/ Osteoporosis (2651); Muscle/Tendon Damage (4532)

Event Date 12/12/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a right shoulder arthroplasty approximately fourteen (14) years ago.Subsequently, the patient underwent the first stage of a two-stage revision surgery approximately a month ago due to aseptic loosening of the implants.A cement spacer was implanted.The second stage of the revision will take place at a later date with new implants.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-00138, 0001822565-2024-00139.D10: medical products: item#: unknown, unknown 16mm bf stem; lot#: unknown.Item#: unknown, unknown 46 keeled glenoid, lot#: unknown.G2: foreign: australia.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the hospital disposed of the product as biohazard.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.H6: component codes: mechanical (g04) - head.Visual examination of the provided pictures identified humeral head.No part or lot information was pictured.Lot identification is necessary for review of device history records, lot identification was not provided.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the humeral implant fit is maintained.There is extensive osteolysis of the glenoid with a non-opaque implant.Loosening cannot be excluded.Alignment is abnormal with humeral implant elevation in relation to the glenoid.Bone quality is osteopenic.The root cause of the reported issue is attributed to no problem found as the head is not related to implant fixation.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: OFFSET MODULAR HUMERAL HEAD 19 MM HEAD HEIGHT 46 MM SPHERICAL HEAD DIAMETER
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED/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: 18484528
• MDR Text Key: 332560231
• Report Number: 0001822565-2024-00105
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K103404
• 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: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00430204619
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization