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

Model Number	113849
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/06/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 0001825034-2022-02315
• Device Sequence Number: 6345740
• Product Code: MBF
• UDI-Device Identifier: 00880304214002
• UDI-Public: (01)00880304214002(17)080630(10)363710
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K030710
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Female