MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PARTIAL FEMUR CEMENTED SIZE 6 RIGHT MEDIAL; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Inflammation (1932); Pain (1994); Swelling (2091); Reaction (2414)

Event Date 01/28/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: associated products : item#:42538000702; partial tibial cemented size g right medial lot#:63720352.Item#:42528200708;partial articular surface right medial size g 8 mm thickness lot#:63784873.Item#:unknown; palacos with gentamycin lot#:unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.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: 0001822565-2020-02388.

Event Description

It was reported that a clinical study patient underwent a right knee tka approximately two years ago.Subsequently the patient had a revision after experiencing pain and inflammation due to a metal allergy.

Manufacturer Narrative

Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no deviations or anomalies were found.Medical records provided state that patient was revised due to metal allergy (nickel allergy), pain and inflammation.It was reported that patient was revised due to allergic reaction, hence the root cause can be attributed towards patient condition.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 6 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
• MDR Report Key: 10233171
• MDR Text Key: 197607195
• Report Number: 3007963827-2020-00171
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00880304808577
• UDI-Public: (01)00880304808577
• 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: 07/31/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42558000602
• Device Lot Number: 63760789
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 07/06/2020
• Supplement Dates Manufacturer Received: 07/30/2020
• Supplement Dates FDA Received: 07/31/2020
• 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): Hospitalization; Required Intervention
• Patient Weight: 81