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

Model Number	N/A
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Swelling/ Edema (4577)
Date of Event	08/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: persona tibia cemented 5 degree stemmed catalog # 42532006702 , lot # 63821043; palacos r 1x40 single catalog # 00111214001 ,lot # 88694748; palacos r 1x40 single catalog # 00111214001 ,lot # 88694748; palacos r 1x40 single catalog # 00111214001 , lot # 87154603; headless trocar drill pin 3.2 mm diameter 75 mm length catalog # 00590102000, lot # 63896087; patella reamer blade with pilot hole 41 mm diameter single use only catalog # 00597909541 lot # 63781509; oscillating saw blade strykerâ® power systems catalog # 25090127yg1 , lot # 68409; articular surface medial congruent (mc) right 12 mm height use with tibia sizes c-d/cr femur sizes 8-9 catalog # 42522100512 , lot # 63473170; all poly patella cemented 32 mm diameter catalog # 42540000032 , lot # 63913695.Customer has indicated that the product will not be returned because it remains implanted.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: 3007963827-2021-00168, 0001822565-2021-02168, 0001822565-2021-02170, 0001822565-2021-02171.Product location is unknown.
Event or Problem Description
It was reported patient underwent a revision procedure 3 years post implantation due to pain, swelling and tibial loosening.The surgeon stated that upon opening noticed that the tibial prosthesis was completely loose and the femoral prosthesis was coming loose.Patient is currently in rehab.Attempts to obtain additional information have been made; however, no more is available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.Per package insert (b)(6): loosening, pain and swelling are known adverse effect of the procedure.X-ray review indicates there is tibial loosening.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 CRUCIATE RETAINING (CR)
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12591427
• Report Number: 3007963827-2021-00201
• Device Sequence Number: 16967173
• Product Code: JWH
• UDI-Device Identifier: 00889024229969
• UDI-Public: (01)00889024229969(17)271130(10)63860583
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2021

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: 42502006602
• Device Lot Number: 63860583
• 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: 09/14/2021
• Supplement Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2017
• 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: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 104 KG