MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MD HYBRID GLENOID BASE 4MM; SHOULDER PROSTHESIS/EXTREMITIES

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 10/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-02927.Concomitant medical products: item#: pt-113950, pt hybrid glen post regenerex; lot#: 436920.Item#: 110031399, hmrl tray std std; lot#: 65171197.Item#: 115313, comp rvsr shldr glnsp +3 36mm; lot#: 636860.Item#: 110031424, hmrl bearing 36 mm std vite; lot#: 65007470.Item#: 110031869, compr aug ream gd bushing; lot#: 64415443.Item#: 110040300, compr aug ream gd screw; lot#: 65106147.Item#: 405883, comp rvs 3.2mm drl; lot#: 556430.Item#: 180550, comp lk scr 3.5hex 4.75x15 st; lot#: 156660.Item#: 180552, comp lk scr 3.5hex 4.75x25 st; lot#: 763080.Item#: 180552, comp lk scr 3.5hex 4.75x25 st; lot#: 484080.Item#: 405800, comp.Rev shldr 9 in steinmann; lot#: 892560.Item#: 405889, comp rvs 2.7mm dia drl; lot#: 493320.Item#: 010000589, comp rvrs 25mm bsplt ha+adptr; lot#: 709970.Item#: 110040202, compr aug 2.7 drl w/stop; lot#: 65106103.Item#: 115395, comp rvs cntrl 6.5x25mm st/rst; lot#: 088840.Item#: 98-0009-000-83, comp shrt st/comp rvs gln e1/ins; lot#: unknown.Item#: 113053, versa-dial 50x21x57 hum head; lot#: 371500.Item#: 118001, versa-dial/comp ti std taper; lot#: 210610.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

T was reported that the patient underwent a right shoulder arthroplasty approximately four (4) years ago for an unknown reason.Subsequently, the patient was revised approximately three (3) weeks ago due to having pain and a tear of the patient's rotator cuff.Upon x-rays, the implant was found to be fractured.The implant fracture was confirmed upon explantation.

Event Description

It was also reported that the tear of the patient's rotator cuff was unrelated to the implants fracturing.

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: 0001825034-2021-02927-1.D10: medical products: item#: 13053, versa-dial 50x21x57 hum head; lot#: 371500 visual examination of the returned products identified the post had fractured with part of it remaining in the base.All of the pieces were returned and bone cement still remained on the pieces.The devices were submitted to sem for further analysis.It was determined that the pt hybrid glenoid post regenerex sample was suspected to be fractured due to fatigue.Most of the fractured surface was either excessively smeared or contaminated by biological debris.Suspected fatigue striations were identified in the non-smeared region near the center of the fracture.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the ap view demonstrates a right shoulder arthroplasty.The humeral head is superiorly displaced consistent with a rotator cuff tear.Bone quality appears osteopenic.There is no fracture or evidence of implant loosening.On the axillary view, there is a fracture of the glenoid post.The root cause of the reported issue is attributed to user error, does not follow instructions.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the 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.

• Brand Name: MD HYBRID GLENOID BASE 4MM
• Type of Device: SHOULDER PROSTHESIS/EXTREMITIES
• 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: 12691821
• MDR Text Key: 278339135
• Report Number: 0001825034-2021-02928
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2022
• Device Model Number: N/A
• Device Catalogue Number: 113954
• Device Lot Number: 711200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2017
• 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; SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male