MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PARTIAL FEMUR CEMENTED; PROSTHESIS KNEE

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Type  Injury  

Event Description

It was reported patient is experiencing pain and bone scan displayed implant loosening approximately one year post implantation.No revision is planned at this time.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

(b)(4).Concomitant medical products: partial tibial cemented catalog # 42538000701, lot # 65036968.Biomet bc r 1x40 us catalog # 110035368, lot # zz44bj2604.Partial articular surface left medial size g 9 mm thickness catalog # 42518200709, lot # 64660677.(b)(4).Multiple mdr reports were filled for this event: 3007963827-2022-00175.Reported event was unable to be confirmed due to limited information received from the customer.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.Medical records review indicates the following mri impression states artifact limiting study with small knee effusion.No loosening can be confirmed based on this mri report.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.

Manufacturer Narrative

Upon receipt of additional information, the initial report was submitted under incorrect manufacturing site.This report will be completed under manufacturing report number 0001825034-2023-00869.

Event Description

Upon receipt of additional information, the initial report was submitted under incorrect manufacturing site.This report will be completed under manufacturing report number 0001825034-2023-00869.

• Brand Name: PARTIAL FEMUR CEMENTED
• Type of Device: 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: 14874094
• MDR Text Key: 295032031
• Report Number: 3007963827-2022-00174
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00880304808478
• UDI-Public: (01)00880304808478(17)300430(10)64646347
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2023

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42558000401
• Device Lot Number: 64646347
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/07/2022
• Initial Date FDA Received: 06/30/2022
• Supplement Dates Manufacturer Received: 04/19/2023
• Supplement Dates FDA Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Race: White