MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS POROUS IM STEM 18.5 X 150; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cp260606 - mod arthro nl 1cm elip cnctr - 55920r.150483 - oss segmental stacking adapter - 490100r.150396 - oss porous im stem 17.5 x 150 - 138150.150482 - oss 4cm diaphyseal segment - 124210.Cp260607 - mod arthro nl 3cm diasl cnctr - 062690.Cp260601 - mod arthro 5 deg lck collar - 996420.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a knee surgery and approximately two years later, the patient was revised due to the porous femoral stem being loose inside the canal.All products except the tibial stem and adapter were revised.Attempts have been made and all available information has been 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.H6 : mechanical (g04) - stem no product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OSS POROUS IM STEM 18.5 X 150
• 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: 18185799
• Report Number: 0001825034-2023-02731
• Device Sequence Number: 12574488
• Product Code: JDI
• UDI-Device Identifier: 00880304239258
• UDI-Public: (01)00880304239258(17)271016(10)932050
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K123501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2024

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: 150397
• Device Lot Number: 932050
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2017
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male