MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PARTIAL FEMUR CEMENTED SIZE 6 LEFT 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 10/29/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: associated products : item#:42538000701; partial tibial cemented size g left medial lot#:63775672.Item#:unknown; bcm-palacos-standard-unk lot#:unknown.Item#:unknown; bcm-gentamycin-unknown-- lot#:unknown.Item#:42518200708; partial articular surface left medial size g 8 mm thickness; lot#:63707718.Reported event was confirmed by review of medical records.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record (dhr) was reviewed and no discrepancies related to the reported event were found.Revision operative notes were provided and it confirms that patient underwent revision due to nickel allergy.During revision the implants were seen to be well fixed and intact.Synovitis was debrided and there were no signs of infection.Office follow up notes prior to surgery stated that patient had pain and swelling.X-rays were provided however they were not sent for review as evaluation would not be able to confirm the presence of a nickel allergy therefore sending images to mmi would not enhance the investigation.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

It is reported the patient had an initial left partial tkr, and subsequently was revised approximately 20 months later due to pain, swelling, and metal allergy.

• Brand Name: PARTIAL FEMUR CEMENTED SIZE 6 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
• 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: 10232789
• MDR Text Key: 197579791
• Report Number: 3007963827-2020-00170
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00880304808492
• UDI-Public: (01)00880304808492
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/06/2020

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: 42558000601
• Device Lot Number: 63700337
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2017
• 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 Weight: 81