MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OFFSET STEM EXTENSION; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Insufficient Information (4580)
Date of Event	11/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent a revision procedure post implantation due to unknown reason.Attempts to obtain additional information have been made; however, no more is available at this time.
Additional Manufacturer Narrative
(b)(4).D10 - medical product: cemented tibial component catalog # 00588000500 lot # 65245291 cemented option femoral component catalog # 00588001601 lot # 64996808 articular surface with hinge post extension catalog # 00588006012 lot # 65154693 g2: spain h3: customer has indicated that the product will not be returned because it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001822565-2023-03589 0001822565-2023-03594 0001822565-2023-03595 h3 other text : discarded.
Additional Manufacturer Narrative
Upon receipt of additional information, patient was revised due to mobility of the tibia.The initial report was submitted in error and should be voided.
Event or Problem Description
Upon receipt of additional information, patient was revised due to mobility of the tibia.The initial report was submitted in error and should be voided.
Additional Manufacturer Narrative
Mechanical (g04) - stem.Initially reported mdr # 0001822565-2023-03593-1 was submitted in error.It is now verified that this device could have caused or contributed to the reported event.Therefore, this is reportable.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot 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 or Problem Description
It was reported patient underwent a revision procedure post implantation due to pain and mobility of the tibia one year post implantation.Attempts to obtain additional information have been made; however, no more is available.

• Brand Name: OFFSET STEM EXTENSION
• Common Device Name: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18317196
• Report Number: 0001822565-2023-03593
• Device Sequence Number: 6152141
• Product Code: JWH
• UDI-Device Identifier: 00889024221475
• UDI-Public: (01)00889024221475(17)300131(10)64516428
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 05/20/2024

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: 00598802014
• Device Lot Number: 64516428
• 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: 12/07/2023
• Supplement Date Received by Manufacturer: 12/19/2023; 05/14/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 01/16/2024; 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown