MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED POSTERIOR STABILIZED (PS) STD RIGHT SIZE 6; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented for an early revision of a knee replacement for infection.Initial surgery was less than three months prior.During the revision the surgeon had difficulty removing the stubby stem as it was disassociated from the tibial tray.No additional information available.
Additional Manufacturer Narrative
(b)(4).G2: new zealand.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 & mdrs: 42532007102 tibia cemented 5 degree stemmed right size e, lot# 65904989.Mdr: 3007963827-2023-00283.42557000114 stem extension tapered cemented 14mm dia +30mm, lot# 65969805.Mdr: 0001822565-2023-02838.42522400710 articular surface fixed bearing (ps) right 10mm, lot# unk.Mdr: 0001822565-2023-02839.42540200029 all-poly patella cemented 29 mm dia, lot# 65777287.Mdr: 0002648920-2023-00248.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.  h6-component code- suggested code: mechanical (g04) - femur.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.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.Complaint is not confirmed.For the infection, review of the sterile certificates determined no problem was found as it was not device related.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: FEMUR CEMENTED POSTERIOR STABILIZED (PS) STD RIGHT SIZE 6
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17938419
• Report Number: 3007963827-2023-00284
• Device Sequence Number: 2971914
• Product Code: JWH
• UDI-Device Identifier: 00889024229204
• UDI-Public: (01)00889024229204(17)270731(10)63742662
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K113369
• 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): 02/06/2024

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: 42500606002
• Device Lot Number: 63742662
• 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: 09/18/2023
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2017
• 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 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female