MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN PRECOAT STEMMED CEMENTED TIBIAL COMPONENT SIZE 6; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994)
Date of Event	01/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - nexgen cemented option femoral component left size f, catalog #: 00599401691, lot #: 62713255.Nexgen posterior femoral augment block size f 5mm, catalog #: 00599003601, lot #: 61518807.Nexgen distal femoral augment block precoat size f 5mm, catalog #: 00599003610, lot #: 62513966.Nexgen straight tibial stem extension 15mm x 30mm, catalog #: 00598801215, lot #: 63118238.Nexgen straight femoral stem extension 16mm x 100mm, catalog #: 00598801016, lot #: 62548446.Nexgen posterior femoral augment block precoat size f 5mm, catalog #: 00599003601, lot #: 61518807.Nexgen distal femoral augment block precoat size f 5mm, catalog #: 00599003610, lot #: 62513966.Nexgen trabecular metal tibial cone full, catalog #: 00545004801, lot #: 63028581.The complainant has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a knee arthroplasty revision to address persistent pain, implant loosening and tibia periprosthetic fracture approximately one (1) year following the patient's last left knee arthroplasty.All components were removed and replaced except for the patellar component.Initial operative notes noted no intraoperative complications.Revision operative notes noted that during removal of the tibial plate, the lateral cortex of the tibia was noted to be splintered.Final components were placed without complications.
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, g3, g6, h2, h3, h6, h11.Medical records provided confirmed the reported bone fracture and pain.Radiographic review of x-rays provided identified anatomic alignment of implants with cement extravasation between the proximal tibia and fibula.No signs of loosening, wear or radiolucency were found.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: NEXGEN PRECOAT STEMMED CEMENTED TIBIAL COMPONENT SIZE 6
• 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: 20145318
• Report Number: 0002648920-2024-00283
• Device Sequence Number: 14511935
• Product Code: JWH
• UDI-Device Identifier: 00889024217614
• UDI-Public: (01)00889024217614(17)250930(10)63166072
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: K933785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 00598004702
• Device Lot Number: 63166072
• 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: 08/17/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2015
• 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 H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 86 KG