MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PARTIAL FEMUR CEMENTED SIZE 4 RIGHT MEDIAL; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 09/16/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 42538000502 - partial tibial cemented size e right medial - 64851015.42528200508 - partial articular surface right medial size e 8 mm thickness - 64660743.Report source: (b)(6).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: 3007963827-2021-00224, 0001822565-2021-02827.

Event Description

It was reported that the patient underwent an initial knee arthroplasty.Subsequently, the patient suffered a medial tibial plateau fracture under the tibia.There were no contributing factors related to the event.The patient had good bone quality.The fracture healed, however, the patient was revised approximately 3 months post-implantation due to continued pain.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records provided were not provided.X-ray review by third party hcp states that medial compartment hemi arthroplasty was seen with oblique fracture involving the medial tibial plateau and associated subsidence of the tibial component of the hemi arthroplasty.Additionally, radiolucency was seen at the bone cement interface of the femoral component of a medial hemi arthroplasty which suggest loosening.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: PARTIAL FEMUR CEMENTED SIZE 4 RIGHT MEDIAL
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12553827
• MDR Text Key: 273998534
• Report Number: 3007963827-2021-00225
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00880304808553
• UDI-Public: (01)00880304808553(17)300720(10)64750404
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42558000402
• Device Lot Number: 64750404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2020
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 100 KG