MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD RIGHT SIZE 9; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Unspecified Infection (1930); Insufficient Information (4580)
Date of Event	02/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2021-00067 and 3007963827-2021-00068.Concomitant medical devices: tibia cemented 5 degree stemmed right size g catalog#: 42532007902 lot#: 63609784.Palacos r + g (1x40) catalog#: 66022663 lot#: 85894585.2.5 mm female hex screw 25 mm length catalog#: 42509902525 lot#: 63668254.Articular surface fixed bearing cruciate retaining (cr) right 11 mm height catalog#: 42522000611 lot#: 62966771.All-poly patella cemented 32 mm diameter catalog#: 42540200032 lot#: 63468118.Foreign source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent right knee revision approximately three and a half years post-implantation due to loosening and possible infection.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
It was reported that a patient underwent right knee revision approximately three and a half years post-implantation due to femoral loosening and possible infection.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
It was reported that a patient underwent right knee revision approximately three and a half years post-implantation due to femoral loosening and possible infection.During the revision, it was noted that there was no cement bonding to the femoral bone.The tibial tray was more stable, but both components were revised.Infection was ruled out via intraoperative cultures.
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.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the provided implant identified sign of use.No bone cement attached to its back femoral implant.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified the following: initial ops noted confirmed that the bone cement was used to complete the surgery.Revision surgery noted found that the femoral component was grossly loose and the tibial plate was well fixed.No infection was noted.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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) STANDARD RIGHT SIZE 9
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 11556052
• Report Number: 3007963827-2021-00067
• Device Sequence Number: 19855571
• Product Code: JWH
• UDI-Device Identifier: 00889024230408
• UDI-Public: (01)00889024230408(17)260630(10)63405136
• 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: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/02/2021

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 Expiration Date: 06/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 42502606602
• Device Lot Number: 63405136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 03/28/2021; 05/20/2021; 06/14/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 04/23/2021; 06/14/2021; 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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 Age: 80 YR
• Patient Weight: 92