MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE SHOULDER SYSTEM MINI HUMERAL STEM; EXTREMITY IMPLANT

Model Number	N/A
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Fungal Infection (2419)
Date of Event	09/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a shoulder arthroplasty approximately a year and a half ago.The implants were mispositioned and the patient experienced discomfort and pain.The patient also had limited range of motion.The implants were well fixated.Patient was revised last week, all implants removed, but a temporary cement spacer in-situ.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
(b)(4).D10 - medical product: catalog #: 115310, comp rvrs shldr glnsp std 36mm, lot # j7147587.Catalog #: 110032410, comp aug mini bsplt w tpr sm, lot # 65172916.Catalog #: 115395, comp rvs cntrl 6.5x25mm st/rst, lot # 414620.Catalog #: 180552, comp lk scr 3.5hex 4.75x25 st, lot # 265350.Catalog #: 180554, comp lk scr 3.5hex 4.75x35 st, lot # 973040.Catalog #: 180550, comp lk scr 3.5hex 4.75x15 st, lot # 099360.Catalog #: 180550, comp lk scr 3.5hex 4.75x15 st, lot # 881060.Catalog #: 110031399, mini tray std cocr +0 offset, lot # 65171155.Catalog #: 110031424, cr vivacit-e 36mm brng std, lot # 65007488.G2: new zealand.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02617, 0001822565-2023-02619, 0001825034-2023-02222, 0001825034-2023-02224 h3 other text : device was discarded.
Additional Manufacturer Narrative
(b)(4).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
It was further reported that during the procedure, it was noted that a fungal infection was present.However, the surgeon noted that this was not a contributing reason for the revision procedure.
Additional Manufacturer Narrative
(b)(4).Proposed g-code: mechanical (g04) - stem.The reported event is confirmed for incorrect placement/orientation per the original surgeon's confirmation and the mmi review.The reported event is not confirmed for infection.Radiographs were provided and identified the following: a reversetype right shoulder arthroplasty is present.The implant alignment and glenosphere position appear abnormal, especially on the oblique/lateral view, with suspected antero/inferior angulation of the glenosphere.The position and alignment would be best evaluated by ct or mri.Implant fit is maintained, however, there is malalignment as noted with apparent malposition of the glenosphere.Bone quality is mildly osteopenic.No signs of loosening, wear, radiolucency, or any other contributing factor that would cause issues with any of the components on the x-ray.No other concerns anatomically or with the implants that could contribute to the patient¿s pain and limited range of motion.Device history record was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is attributed to use error, surgeon mispositioning implants.Infection: the root cause of the reported event was determined to be unrelated to the implanted zimmer biomet devices; therefore, a review of the device history records will not be performed.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: COMPREHENSIVE SHOULDER SYSTEM MINI HUMERAL STEM
• Common Device Name: EXTREMITY IMPLANT
• 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: 17816932
• Report Number: 0001825034-2023-02223
• Device Sequence Number: 2480401
• Product Code: HSD
• UDI-Device Identifier: 00880304462649
• UDI-Public: (01)00880304462649(17)280414(10)936530
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K060692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 02/29/2024

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 Model Number: N/A
• Device Catalogue Number: 113629
• Device Lot Number: 936530
• 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: 08/31/2023
• Supplement Date Received by Manufacturer: 10/24/2023; 02/26/2024
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 11/20/2023; 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2018
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 84 KG