MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN STEMMED NONAUGMENTABLE 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	Extraskeletal ossification (1428); Bone Fracture(s) (1870); Failure of Implant (1924); Necrosis (1971); Pain (1994); Synovitis (2094); Ambulation or Postural Difficulties (2544)
Date of Event	08/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient became symptomatic, absent trauma, he developed pain in his left knee approximately four years and three months post implantation.An x-ray one month later demonstrated loosening of the tibial component.The patient was advised to undergo revision knee replacement surgery.He was listed for revision.Whilst on waiting list he developed a peri-prosthetic fracture around the tibial plateau about four months after the loosening was diagnosed.He then underwent emergency revision surgery two days later.
Additional Manufacturer Narrative
(b)(4).G2: great britain.The product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, g3, g6, h1, h2, h3, h6, h11 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history records were reviewed for deviations and/or anomalies with no related anomalies/deviations found.The reported products were reviewed for compatibility with no issues noted.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: inflammatory synovium encountered, periprosthetic fracture visualized over proximal tibia, implants and cement removed, 'decision taken to retain the patella poly and to retain the fractured tibial bone fragment', fracture reduction achieved using 2 button sutures, stable and checked under xray, stability checked after cerament application, acceptable, irrigation and closure, no intraop complications, hinge knee brace applied.Radiographs: x-rays in zip file assessed; however, they are dated post first stage revision.Sending the images would not enhance the investigation) this complaint can be confirmed based on the medical records.A definitive root cause cannot be determined.No new corrective actions, preventive actions, or field actions resulted after investigation of this event.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: NEXGEN STEMMED NONAUGMENTABLE 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: 20171809
• Report Number: 0002648920-2024-00288
• Device Sequence Number: 7002501
• Product Code: JWH
• UDI-Device Identifier: 00889024218864
• UDI-Public: (01)00889024218864(17)260228(10)63284007
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2024

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 Expiration Date: 02/28/2026
• Device Model Number: N/A
• Device Catalogue Number: 00598604702
• Device Lot Number: 63284007
• 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: 08/15/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2016
• 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: ZFA-2022-00240
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 112 KG