MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD LEFT SIZE 5; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Implant date : 2018.Concomitant medical device(s): 42512100312 - articular surface medial congruent (mc) left 12 mm height use with tibia sizes c-d/cr femur sizes 4-5 - 63686912; 42532006701 - tibia cemented 5 degree stemmed left size d - 64156330.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00419.
Event or Problem Description
It was reported that the patient underwent an initial knee surgery.Subsequently, the patient was revised approximately 5 years later due to femoral loosening.During the surgery, it was noted that poly was pitted and was also revised.There were no contributing conditions.There was no surgical delay.The surgical technique was utilized.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
H6 : mechanical (g04) - femur.Visual examination of the provided pictures identified shows for the femoral a foreign material is found on the surface.As no products were returned further 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.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the bones are otherwise unremarkable and the hardware appears intact.No fracture or dislocation.No loosening of the femoral component is confirmed radiographically.There's also possible polyethylene lining loss, given lack of spacing in the patellofemoral compartment.The overall fit and alignment of the implants is normal.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: FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD LEFT SIZE 5
• 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: 16407896
• Report Number: 3007963827-2023-00022
• Device Sequence Number: 17723863
• Product Code: JWH
• UDI-Device Identifier: 00889024230316
• UDI-Public: (01)00889024230316(17)261231(10)63547079
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42502605801
• Device Lot Number: 63547079
• 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: 02/01/2023
• Supplement Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2016
• 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: Female