MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X40MM ST/RST; EXTREMITY IMPLANTS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	01/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical product: catalog #: 405800, comp.Rev shldr 9 in steinmann, lot # 130520.Catalog #: 115310, comp rvrs shldr glnsp std 36mm, lot # 886240.Catalog #: 180550, comp lk scr 3.5hex 4.75x15 st, lot # 437540.Catalog #: 180550, comp lk scr 3.5hex 4.75x15 st, lot # 098780.Catalog #: 180551, comp lk scr 3.5hex 4.75x20 st, lot # 918800.Catalog #: 180551, comp lk scr 3.5hex 4.75x20 st, lot # 855910.Catalog #: 010000589, comp rvrs 25mm bsplt ha+adptr, lot # 656600.Catalog #: 113611, comp primary stem 11mm micro, lot # 65319533.Catalog #: 110031424, cr vivacit-e 36mm brng std, lot # 65434165.Catalog #: 110031399, mini tray std cocr +0 offset, lot # 65398274.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its 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: 0001825034-2023-00354, 0001825034-2023-00355, 0001825034-2023-00356, 0001825034-2023-00357, 0001825034-2023-00358, 0001825034-2023-00359, 0001825034-2023-00361, 0001825034-2023-00362, 0001822565-2023-00438, and 0001822565-2023-00439.
Event or Problem Description
It was reported that the patient was revised approximately 3 months post implantation due to an suspected nickel allergy.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
(b)(4).Upon reassessment of the reported event, it was determined to be not reportable.Only the steinmann pin contains nickel, which is the confirmed metal allergy allegation.This product is confirmed to not contain nickel; therefore, the initial report should be voided.
Event or Problem Description
Upon reassessment of the reported event, it was determined to be not reportable.Only the steinmann pin contains nickel, which is the confirmed metal allergy allegation.This product is confirmed to not contain nickel; therefore, the initial report should be voided.

• Brand Name: COMP RVS CNTRL 6.5X40MM ST/RST
• Common Device Name: EXTREMITY IMPLANTS
• 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: 16410308
• Report Number: 0001825034-2023-00360
• Device Sequence Number: 12170254
• Product Code: KWS
• UDI-Device Identifier: 00880304677104
• UDI-Public: (01)00880304677104(17)320719(10)655670
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K193373
• 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: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

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: 115398
• Device Lot Number: 655670
• 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: 01/24/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female