MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING (CR) NARROW; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent a revision procedure eight months post implantation due to fractured medical condyle as per radiographs.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
(b)(4).D10 - medical product: 2.5 mm female hex screw 25 mm length catalog # 42509902525, lot # 65390792.Cas fixation pin 3.2d x 150mm sterile catalog # 20800000010, lot # 64978939.All-poly patella cemented 29 mm diameter catalog # 42540200029, lot # 65238881.Articular surface medial congruent (mc) right 10 mm height use with tibia sizes c-d/cr femur sizes 8-9 catalog # 42522100510, lot # 64633743.Tibia cemented 5 degree stemmed right size d catalog # 42532006702, lot # 65303444.Iassist pin & screw pack sterile catalog # 20800000020, lot # 65184126.G2: australia.H3: customer has indicated that the product will not be returned because requested but not returned by hospital.Once the investigation has been completed, a follow-up mdr will be submitted.
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: suggested code: mechanical g4-femur.Reported event was confirmed by review of x-rays provided.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.X-ray review identified and confirms the bone fracture.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: FEMUR CEMENTED CRUCIATE RETAINING (CR) NARROW
• 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: 17040390
• Report Number: 3007963827-2023-00137
• Device Sequence Number: 7011828
• Product Code: JWH
• UDI-Device Identifier: 00889024229969
• UDI-Public: (01)00889024229969(17)301031(10)64839120
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113369
• 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
• Report Date (Section B): 08/11/2023

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: 42502006602
• Device Lot Number: 64839120
• 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: 05/08/2023
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 95 KG