MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. STEMMED TIBIAL COMPONENT PRECOAT SIZE 2; PROSTHESIS, KNEE

Catalog Number	00598002702
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	04/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: articular surface size cd 10 mm height: catalog#: 00596202210, lot#: 64629352; femoral component option size d left: catalog#: 00596401451, lot#: 65478507.G2: foreign: china.Multiple mdr reports have been filed for this event.Please see associated reports: 0001822565-2023-03795; 3007963827-2023-00358.The product will not be returned to zimmer biomet for investigation, as the product currently remains implanted.The investigation is in process.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 that a patient underwent an initial right total knee arthroplasty.Subsequently, two days post-implantation, the patient displayed thrombosis of the interosseous and peroneal vein in the left calf.The patient was instructed to increase water intake and rehabilitation exercises and continued blood clot prevention medication as prescribed.The complication with the patient was reported to be resolved and the prosthesis remains implanted.It was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbidities, and perioperative management.Deep vein thrombosis (blood clot), or dvt, occurs when a blood clot forms in one of the deep veins of the body.This can happen if a vein becomes damaged or if the blood flow within a vein slows down or stops.Total joint patients are typically placed on medication post-operatively to prevent dvt formation.Even with the administration of preventive medication, dvts can still develop.As the complaint indicated, a post-operative complication occurred, and medical intervention was required for treatment.As there are multiple factors that may contribute to post-operative swelling and muscle atrophy that are outside the control of zimmer biomet, the root cause of the reported event was determined to be not related to the device.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.

• Brand Name: STEMMED TIBIAL COMPONENT PRECOAT SIZE 2
• 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: 18419670
• Report Number: 0002648920-2023-00320
• Device Sequence Number: 15445029
• Product Code: JWH
• UDI-Device Identifier: 00889024217560
• UDI-Public: (01)00889024217560(17)320813(10)65521107
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 00598002702
• Device Lot Number: 65521107
• 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: 12/05/2023
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2022
• 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.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Female