MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. STEMMED TIBIAL COMPONENT PRECOAT SIZE 4; PROSTHESIS, KNEE

Model Number	5980-37-02
Medical Device Problem Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Ambulation or Postural Difficulties (2544)
Date of Event	04/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A2: year of birth: 1964.D6a: exact implantation date is unknown but occurred in 2017.D10: unknown femoral component: catalog#ni, lot #ni; unknown articular surface: catalog#ni; lot#ni.G2: foreign: germany user facility: bfarm user report reference: 10211/23 diligence is in process to determine whether the product is available for evaluation.The investigation is in progress.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.H3 other text : see h10 narrative.
Event or Problem Description
It was reported via a competent authority user report that a patient underwent an initial left total knee arthroplasty.Subsequently, six (6) years post-implantation, the patient experienced a fracture of the tibial component.A revision surgery was performed in which the complete prosthesis system was replaced.Due diligence is in progress for this event; to date no further information has been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified a broken articular surface and a broken tibial plate.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: pre-op diagnosis of fractured tibial component, patient noted pain and instability, excision of scar tissue, medial plateau was sunk about 1 cm, a drain was placed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: fracture of hyper-dense material along the medial tibial plateau, no bony joint fracture.Root cause was unable to be determined.This complaint was confirmed by the pictures of the explanted items being fractured, the medical records, and the x-ray images.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 at time of this report.
Event or Problem Description
It was reported via a competent authority user report that a patient underwent an initial left total knee arthroplasty.Subsequently, six (6) years post-implantation, the patient experienced a fracture, pain, and instability.During the revision surgery fracture of the tibial component and articular surface were noted as well as scar tissue and tibial plateau subsidence without loosening.A revision surgery was performed in which the complete prosthesis system was replaced.Due diligence is complete as multiple attempts have been made however it was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: articular surface regular constraint size yellow/c-h 10 mm height: catalog# 90597003010, lot#63667284; femoral component precoat size e left: catalog#00595001501, lot#63636144; palacos r+g 2x20: catalog#66017775, lot#85785278, (b)(4); palacos r+g 2x40: catalog#6017747, lot#86324612.Multiple mdr reports have been filed for this event.Please see associated report: 0001822565-2023-01476.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.

• Brand Name: STEMMED TIBIAL COMPONENT PRECOAT 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: 16854706
• Report Number: 0002648920-2023-00082
• Device Sequence Number: 7566393
• Product Code: JWH
• UDI-Device Identifier: 00889024217584
• UDI-Public: (01)00889024217584(17)270228(10)63609055
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/10/2023

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: 5980-37-02
• Device Catalogue Number: 00598003702
• Device Lot Number: 63609055
• 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: 04/11/2023
• Supplement Date Received by Manufacturer: 05/11/2023; 08/02/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 06/01/2023; 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2017
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female