MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BMT SPLINED KNEE STM V2 14X80; PROSTHESIS, KNEE

Catalog Number	148304
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: australia.Suggested code (annex g)- mechanical (g04) - stem.The product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products (b)(6), vanguard bmt 360 tib tray 67mm lot# 441340, b)(6), vanguard bmt 360 7.5mm offset adapter lot# 391790, b)(6), vanguard ssk psc tib brg 14x63/67 lot# 699650, b)(6), vanguard bmt 360 tib lg cruciate wing.
Event or Problem Description
It was reported that the patient was revised approximately six years post implantation due to pain.Bone scans prior to revision suggest infection, stress response.No further records provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected, updated: b4, b5, d5, g3, g6, h1, h2, h3, h6, h10, h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.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.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: visit 1; bone scan: blood pooling associated with left knee tibial stem this is consistent with either loosening or infection, femoral component unremarkable.Visit 2: persistent changes still unclear if loose, or if stress reaction, not settling; persistent ache patient reports it is affecting her life; patient whishes to proceed with revision.Visit 3; left knee revision: general anesthesia with femoral nerve block, asa ii.Complaint is confirmed with the provided medical records.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.

• Brand Name: BMT SPLINED KNEE STM V2 14X80
• 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: 21688262
• Report Number: 0001825034-2025-00822
• Device Sequence Number: 8820206
• Product Code: JWH
• UDI-Device Identifier: 00880304528871
• UDI-Public: (01)00880304528871(17)260128(10)656980
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121149
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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: Lay User/Patient
• Device Expiration Date: 01/28/2026
• Device Catalogue Number: 148304
• Device Lot Number: 656980
• 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: 02/28/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2016
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 67 KG