MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET SPLINED KNEE STEM V2 19MM X 80MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Rash (2033); Chills (2191); Dizziness (2194); Depression (2361); Blister (4537); Eczema (4547)

Event Type  Injury  

Event 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.

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 splined knee stem v2 16mm x 80mm catalog #: 148306, lot #: 614600, 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.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, 0001825034-2023-01333, 0001825034-2023-01334, 0001825034-2023-01335, 0001825034-2023-01336.

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 Description

No further event information available at the time of this report.

• Brand Name: BIOMET SPLINED KNEE STEM V2 19MM X 80MM
• Type of Device: 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: 17133896
• MDR Text Key: 317213422
• Report Number: 0001825034-2023-01337
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00880304545564
• UDI-Public: (01)00880304545564(17)281107(10)332930
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 148309
• Device Lot Number: 332930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/30/2023
• Initial Date FDA Received: 06/15/2023
• Supplement Dates Manufacturer Received: 11/28/2023
• Supplement Dates FDA Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 62 KG