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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: partial tibial cemented; p/n: 42538000302, l/n: 63846899.Partial femur cemented; p/n: 42558000102, l/n: 63700309.Partial articular surface; p/n: 42528200308, l/n: 63864916.Report source: foreign: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to it remains implanted.The investigation is in process and once the investigation has been completed, a follow-up mdr will be submitted.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 Description

It was reported a patient underwent initial knee arthroplasty six months post-implantation.Subsequently, it was discovered the patient tibia bone fractured no additional patient consequences were reported.

Event Description

It was reported patient tibia bone fractured 13 days post-implantation.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

This follow-up report is being submitted to relay updated and additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: PARTIAL TIBIAL 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
• MDR Report Key: 8183850
• MDR Text Key: 130975069
• Report Number: 3007963827-2018-00224
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• 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: 42538000302
• Device Lot Number: 63846899
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR