MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BMT SPLINED KNEE STM V2 16X80; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient was revised approximately four years post implantation due to femoral loosening and pain.The femoral, offset adapter and stem were revised for cause.Articular surface was exchanged as best practice.All other implants remained.No product is available for return as it was discarded by the the facility.
Additional Manufacturer Narrative
(b)(4).G2: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded by the facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs: 185262 vngd ssk 360 r fem 60mm lot# 3462161.Mdr: 0001825034-2023-02721.185210 bmt 360 2.5mm offset adapter lot# 268100 mdr: 0001825034-2023-02723 additional associated products ----------------------------------------------- 185086 vngd ssk ps tib brg 16x71/75 lot# 963270 148289 bmt splined knee stm v2 14x40 lot# 963020 185211 bmt 360 tib 5.0 offset adapter lot# 134970 185203 bmt 360 tib tray 71mm lot# 503010 185651 bmt 360 tib lg cruciate wing lot# 002760 185223 bmt 360 tib aug 71x5mm lot# 759970 185223 bmt 360 tib aug 71x5mm lot# 176410 66056768 palacos r+g fast lot# 92734904.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.  h6-component code- suggested code: mechanical g4-stem.Visual examination of the provided pictures identified the femoral implant implanted in the patient.The stem, adaptor and femoral in the second picture are explanted with foreign material on their surfaces.As the devices were not returned, further evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Review of complaint history found no additional related issues for these items and the reported part and lot combinations.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right total knee arthroplasty with loosening of the femoral and possibly tibial components.Overall fit alignment of the implants appears to be appropriate.Mild osteopenia.Complaint is confirmed from the provided radiographs.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event 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: BMT SPLINED KNEE STM V2 16X80
• 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: 18184178
• Report Number: 0001825034-2023-02722
• Device Sequence Number: 7567799
• Product Code: JWH
• UDI-Device Identifier: 00880304529038
• UDI-Public: (01)00880304529038(17)290204(10)222300
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121149
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 04/26/2024

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: 148306
• Device Lot Number: 222300
• 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: 10/27/2023
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2019
• 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: Hospitalization; Required Intervention
• Patient Sex: Male