MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIO-MOD GLEN 4MM ALL-POLY SMAL; PROSTHESIS, SHOULDER

Model Number 113849

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 09/06/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent an initial left total shoulder arthroplasty.Subsequently, the patient was revised for anatomic glenoid loosening.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).Concomitant medical products: part: 11-113705, lot: 438620, bio-mod st.9x115 w/align hole w/aln hole.Part: 113763, lot: 411770, bio-mod hum head 44diax15mm 15mm.Part: 110019066, lot: 280000, compr vrs bone & implant model.Part: 405800, lot: 684630, comp.Rev shldr 9 in steinmann.Part: 405889, lot: 840220, comp rvs 2.7mm dia drl.Part: 405889, lot: 840280, comp rvs 2.7mm dia drl.Part: 113632, lot: 65066752, comp primary stem 12mm mini.Part: 110031402, lot: 65362543, hmrl tray +3 std.Part: 110031427, lot; 65337933, hmrl bearing 40 mm std vite.Part: 110027734, lot: 279950, comp vrs implt w mi tpr adptr.Part: 110031378, lot: 513750, versa-dial taper adaptor 25mm.Part: 115399, lot; 641330r, comp rvs cntrl 6.5x45mm st/rst.Part: 180554, lot: 241190, comp lk scr 3.5hex 4.75x35 st.Part: 180555, lot: 973080, comp lk scr 3.5hex 4.75x40 st.Part: 180555, lot: 072240, comp lk scr 3.5hex 4.75x40 st.Part: 180551, lot: 729100, comp lk scr 3.5hex 4.75x20 st.Part: 110030776, lot: 65411933, 40 mm versa-dial glen std.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the hospital.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 02312.

• Brand Name: BIO-MOD GLEN 4MM ALL-POLY SMAL
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15626803
• MDR Text Key: 301942604
• Report Number: 0001825034-2022-02315
• Device Sequence Number: 1
• Product Code: MBF
• UDI-Device Identifier: 00880304214002
• UDI-Public: (01)00880304214002(17)080630(10)363710
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030710
• 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
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2008
• Device Model Number: 113849
• Device Catalogue Number: 113849
• Device Lot Number: 363710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: 78 YR
• Patient Sex: Female