MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X30MM ST/RST; EXTREMITIES IMPLANT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); Metal Related Pathology (4530)
Date of Event	07/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent a procedure approximately 4 years ago.Subsequently, the patient was revised about a month ago due to pain, reactive tissue, fluid in the capsule, and tissue between the baseplate and glenosphere.There is possible metallosis or allergy.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 # 263010 catalog #: 110032410, comp aug mini bsplt w tpr s, lot # 64314041 catalog #: 115370, comp rvs tray co 44mm, lot # 403720 catalog #: 180553, comp lk scr 3.5hex 4.75x30 st, lot # 606680 catalog #: 180552, comp lk scr 3.5hex 4.75x25 st, lot # 504390 catalog #: 180552, comp lk scr 3.5hex 4.75x25 st, lot # 427570 catalog #: 113631, comp primary stem 11mm mini, lot # 733660 catalog #: ep-115393, e1 44-36 std hmrl brng, lot # 961790 h3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the has been requested but not returned by hospital.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: 0001825034-2023-02027, 0001825034-2023-02028, 0001825034-2023-02029, 0001825034-2023-02030, 0001825034-2023-02031, 0001825034-2023-02032, 0001825034-2023-02033, 0001825034-2023-02041 h3 other text : requested but not returned by hospital.
Additional Manufacturer Narrative
(b)(4).Updated: b4, b5, d2, e1, g3, h1, h2, h3, h6, h10 reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: COMP RVS CNTRL 6.5X30MM ST/RST
• Common Device Name: EXTREMITIES 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: 17643914
• Report Number: 0001825034-2023-02034
• Device Sequence Number: 14861098
• Product Code: KWS
• UDI-Device Identifier: 00880304677081
• UDI-Public: (01)00880304677081(17)281010(10)919910
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 115396
• Device Lot Number: 919910
• 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: 08/04/2023
• Supplement Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2018
• 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: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 59 KG