MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP LK SCR 3.5HEX 4.75X45 ST; SHOULDER, PROSTHESIS

Model Number	180556
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: foreign: australia.Concomitant medical products: mini tray std cocr +0 offset cat: 110031399 lot: 64796738 cr vivacit-e 36mm brng std cat: 110031424 lot: 64653574.Reverse shoulder mini guide and bone model right cat: 20809000302 lot: 934879.Comp rvrs 25mm bsplt ha+adptr cat: 010000589 lot: 029220.Comp primary stem 5mm mini cat: 113625 lot: 740580.Comp rvs cntrl 6.5x20mm st/rst cat: 115394 lot: 755340.Comp rvs cntrl 6.5x35mm st/rst cat: 115397 lot: 877410.Comp lk scr 3.5hex 4.75x25 st cat: 180552 lot: 131960.Comp lk scr 3.5hex 4.75x25 st cat: 180552 lot: 272560.Cas fixation pin 3.2d x 80mm sterile cat : 20800000011 lot : 64808911.Comp.Rev shldr 9 in steinmann cat : 405800 lot: 785220.Comp.Rev shldr 9 in steinmann cat: 405800 lot: 785240.Comp rvs 2.7mm dia drl cat: 405889 lot: 122460.Comp rvrs shldr glnsp std 36mm cat: 115310 lot: 560050.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.
Event or Problem Description
It was reported that the patient was revised due to pain and stiffness.The glenosphere, humeral poly, tray and baseplate screw were removed and replaced.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were 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 or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: pain, stiffness, esr slightly elevated.Negative culture and gram stain on humeral tray and stem.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: COMP LK SCR 3.5HEX 4.75X45 ST
• Common Device Name: SHOULDER, PROSTHESIS
• 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: 14688902
• Report Number: 0001825034-2022-01339
• Device Sequence Number: 6636968
• Product Code: KWS
• UDI-Device Identifier: 00880304677197
• UDI-Public: (01)00880304677197(17)300220(10)939530
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K132239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 180556
• Device Catalogue Number: 180556
• Device Lot Number: 939530
• 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: 03/10/2022
• Supplement Date Received by Manufacturer: 06/02/2022; 08/04/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 07/01/2022; 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 61 KG