MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIO-MOD ST. 9X115 W/ALIGN HOLE W/ALN HOLE; PROSTHESIS, SHOULDER

Model Number	11-113705
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
Additional Manufacturer Narrative
(b)(4).(b)(4).Concomitant medical products: part: 113763 lot: 411770 bio-mod hum head 44diax15mm 15mm.Part: 113849 lot: 363710 bio-mod glen 4mm all poly smal.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 -02315.
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.

• Brand Name: BIO-MOD ST. 9X115 W/ALIGN HOLE W/ALN HOLE
• 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: 15626946
• Report Number: 0001825034-2022-02312
• Device Sequence Number: 15039136
• Product Code: MBF
• UDI-Device Identifier: 00880304204492
• UDI-Public: (01)00880304204492(17)130531(10)438620
• 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: 05/31/2013
• Device Model Number: 11-113705
• Device Catalogue Number: 11-113705
• Device Lot Number: 438620
• 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
• Date Device Manufactured: 05/01/2003
• 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
• Patient Age: 78 YR
• Patient Sex: Female