MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE D; PROSTHESIS, KNEE

Model Number N/A

Device Problems Loss of Osseointegration (2408); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 03/03/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Implant date : (b)(6) 2019.Concomitant medical products: 42500606202 - femur cemented posterior stabilized (ps) standard right size 7 - 64145745.42557000114 - stem extension tapered cemented 14 mm diameter +30 mm length - 64178050.42540000031 - persona all poly patella 32mm - 64203158.42522600510 - e fixed bearing constrained posterior stabilized (cps) right 10 mm height use with tibia sizes c-d / ps femur sizes 6-9 - 63376326.66022663 - palacos r + g (1x40) - 88354675.Report source : foreign country : canada.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.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2023-00060, 0001822565-2023-00800, 0002648920-2023-00054.

Event Description

It was reported that the patient underwent an initial knee surgery.Approximately 3.5 years later, the patient underwent the first stage of a revision due to implant failure.Both femoral and tibial components were loose after noted bone loss.No infection was found in the patient at this point, however, intraop samples have been sent to be evaluated.Attempts have been made and all available information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned products found them to exhibit signs of being implanted scratched / nicked / foreign material.The device history record was reviewed and no discrepancies relevant to the reported event were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: overall fit and alignment of the implants appears to be appropriate, bony resorption of the distal femur and possible loosening of the tibial component.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.

Event Description

No further event information available at the time of this report.

• Brand Name: TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE D
• 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: 16635661
• MDR Text Key: 312214161
• Report Number: 3007963827-2023-00059
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024471047
• UDI-Public: (01)00889024471047(17)280731(10)64072867
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/27/2023

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: 42532006702
• Device Lot Number: 64072867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2023
• Initial Date FDA Received: 03/29/2023
• Supplement Dates Manufacturer Received: 07/26/2023
• Supplement Dates FDA Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2018
• 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.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose