MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS 3CM ELLIP DIAPHYSEAL SEG; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Swelling/ Edema (4577)
Date of Event	09/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: new zealand.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: 150355 oss 7cm segmental femoral lt lot# 858000.Mdr: 0001825034-2023-02410.150364 oss cemented im stem 17mmx90mm lot# 476360.Mdr: 0001825034-2023-02412.Additional associated products: 150480 oss axle lot# 65816566.150411 oss tibial poly bearing 14mm, lot# 486770r.
Event or Problem Description
It was reported patient was revised on the left knee due to a peri-prosthetic fracture two months post implantation of oss distal femur.No additional information provided by hcp.
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.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.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: left total knee hinged arthroplasty with distal femoral resection and fracture of the medial aspect of the distal femoral cortex with associated loosening.Overall fit and alignment of the implant is appropriate.Complaint is confirmed with 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.

• Brand Name: OSS 3CM ELLIP DIAPHYSEAL SEG
• 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: 17956282
• Report Number: 0001825034-2023-02411
• Device Sequence Number: 12514391
• Product Code: JDI
• UDI-Device Identifier: 00880304239821
• UDI-Public: (01)00880304239821(17)320811(10)536200
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K002757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 02/08/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 150461
• Device Lot Number: 536200
• 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: 09/30/2023
• Supplement Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male