MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. STEMMED NONAUGMENTABLE TIBIAL COMPONENT CR/PS/LPS SIZE 4; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products 00599403217 17mm height size e, f with locking screw lot#: 65672721.00599401692 right size f cemented option femoral component lot#: 65460754.Unk cement.
Event or Problem Description
It was reported the patient was revised for knee pain approximately 5 years post implantation.It was found that the tibial implant was loose with no cement adhered to the titanium surface.Tibial implant was revised for loosening and the articular surface and femoral implant were revised as best practice.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Complaint is not confirmed.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
No further event information available at the time of this report.
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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.It was found that the tibial implant is not compatible with the lcck femoral and articular surface.From the ifu, 'lcck components can only be used with stemmed tibial baseplate components that include a stem extension' and 'appropriate matching of components will occur when the femoral and tibial baseplate colors and/or sizes are matched to the articular surface label.Mismatching may result in poor surface contact and could produce pain, decrease wear resistance, produce instability of the implant, or otherwise reduce implant life.' it is unknown if this combination of products contributed to the reported issue.A definitive root cause cannot be determined.Complaint is not confirmed.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: STEMMED NONAUGMENTABLE TIBIAL COMPONENT CR/PS/LPS SIZE 4
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18233938
• Report Number: 0002648920-2023-00290
• Device Sequence Number: 17888485
• Product Code: JWH
• UDI-Device Identifier: 00889024218840
• UDI-Public: (01)00889024218840(17)280331(10)63985865
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00598603702
• Device Lot Number: 63985865
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 03/19/2024; 03/22/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 03/19/2024; 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 106 KG