MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET SPLINED KNEE STEM V2 16MM X 80MM; PROSTHESIS, KNEE

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); Rash (2033); Chills (2191); Dizziness (2194); Depression (2361); Blister (4537); Eczema (4547)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - vanguard ssk constrained ps tibial bearing 16mm x 71/75mm catalog #: 183886 lot #: 822080, vanguard ssk 360 femoral component with screw 65mm right catalog #: 185264 lot #: 6533735, biomet 360 tibial tray 71mm catalog #: 185203 lot #: 536110, biomet 360 tibial cruciate wing small catalog #: 185650 lot #: 805190, vanguard 360 posterior femoral augment with bolt 65mm x 5mm catalog #: 185344 lot #: 490590, vanguard 360 posterior femoral augment with bolt 65mm x 5mm catalog #: 185344 lot #: 685480, biomet splined knee stem v2 19mm x 80mm catalog #: 148309 lot #: 332930.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.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 patient; please see all reports associated with this event: 0001825034-2023-01330, 0001825034-2023-01331, 0001825034-2023-01332, 0001825034-2023-01334, 0001825034-2023-01335, 0001825034-2023-01336, 0001825034-2023-01337.
Event or Problem Description
It was reported that approximately three (3) years following right knee arthroplasty, the patient continues to experience pain, brain fog, depression, a rash on the knee, blisters, eczema, dizziness, blackouts and difficulty getting out of bed.The patient is currently discussing next steps with the surgeon.Initial operative notes noted no complications while the components were placed.
Additional Manufacturer Narrative
Medical records received were reviewed and confirmed no intraoperative complications.However, no additional records were provided to confirm the reported post-operative complications.The device history records were reviewed and no discrepancies were identified.During the investigation, the zimmer persona patella button was identified to have been used with the biomet ssk femur.Per the persona instructions for use, components and/or instruments from other knee systems should not be used with the persona system unless expressly labeled for such use, as this may result in premature wear, loosening or implant fracture that requires surgical intervention.Additionally, the patient was noted to have a component implanted containing metal the patient reported being allergic to.However, without additional medical records and based on the information provided, 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: BIOMET SPLINED KNEE STEM V2 16MM X 80MM
• Common Device Name: PROSTHESIS, KNEE
• 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: 17133934
• Report Number: 0001825034-2023-01333
• Device Sequence Number: 17754412
• Product Code: JWH
• UDI-Device Identifier: 00880304529038
• UDI-Public: (01)00880304529038(17)290912(10)614600
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K121149
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2023

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: 148306
• Device Lot Number: 614600
• 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: 05/30/2023
• Supplement Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2019
• 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 NARRATIVE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 62 KG