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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Swelling (2091); Reaction (2414); Swelling/ Edema (4577)
Date of Event	10/29/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6; h11 h6: component code: mechanical (g04) - femur the reported event was confirmed.No devices were received; therefore the condition of the components is unknown.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records provided state that patient was revised due to metal allergy (nickel allergy), pain and inflammation.Additional medical records provided state that patient was experiencing pain with swelling.Per instructions for use per component description, the femoral component contain the elements that patient is allergic to.The ifu also states under adverse effects material sensitivity and is a known inherent risk.The root cause is attributed to use error via a failure to follow instructions.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 6 LEFT MEDIAL
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• 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
• Report Number: 3007963827-2020-00170
• Device Sequence Number: 3093090
• Product Code: HSX
• UDI-Device Identifier: 00880304808492
• UDI-Public: (01)00880304808492
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42558000601
• Device Lot Number: 63700337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 11/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White