MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PARTIAL FEMUR CEMENTED SIZE 3 LEFT MEDIAL; PROSTHESIS, KNEE

Model Number N/A

Device Problems Unstable (1667); Noise, Audible (3273)

Patient Problems Pain (1994); Swelling (2091)

Event Date 07/10/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 42518200408 - articular surface - 63424640.42538000401 - tibial component - 63441156.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.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: 0001822565-2021-00328, 0001822565-2021-00329.

Event Description

It was reported that patient underwent left unilateral knee arthroplasty.At the one & two year visits, the patient reports moderate pain, noise, and feeling of instability.The patient was diagnosed with pes anserine bursitis without reported treatment or intervention and a neuroma for which the patient received oral medication for nerve pain.At the two year visit, the patient reported persistent pain with no clinical indication of device complications.The patient was instructed to return in 5 years.

Manufacturer Narrative

No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The dhr was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Review found at 1 year follow up patient had pain with normal alignment and stability.X-rays have no significant radiographic findings.Pain with activities and clicking.Treated with ibuprofen.Continues to have swelling.At 1.5 year check in symptoms have improved but continues to have pain with activity, swelling, and instability, feels as though knee buckles.Diagnosed with neuroma, prescribed gabapentin for nerve pain.Patient has a history of fibromyalgia and chronic pain.At 2 year follow up continues to have pain, small effusion and satisfactory rom.Xrays reveal good prosthesis alignment, satisfactory hardware placement, no evidence of prosthesis 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.

Event Description

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

• Brand Name: PARTIAL FEMUR CEMENTED SIZE 3 LEFT 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
• MDR Report Key: 11285671
• MDR Text Key: 230473361
• Report Number: 3007963827-2021-00027
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00880304808461
• UDI-Public: (01)00880304808461(17)270228(10)63607288
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• 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: 42558000301
• Device Lot Number: 63607288
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Other
• Patient Weight: 88