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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Fever (1858); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Chills (2191); Malaise (2359); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02562, 0001822565-2023-02563, and 0002648920-2023-00221.D10 medical devices: femoral component precoat size f right catalog#: 00596001652 lot#: 61805179 articular surface size ef 12 mm height catalog#: 00596204012 lot#: 61710730 all poly patella standard cemented size 35 mm diameter 9.0 mm thickness catalog#: 00597206535 lot#: 61866385 g2 foreign source: australia due to the patient being bilateral and the invoice not clarifying, the right knee either has this device implanted or: stemmed tibial component precoat size 6 catalog#: 00598004702 lot#:61819673 expiration date: jun 14, 2021 manufacture date: jun 17, 2011 customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient underwent an initial right knee arthroplasty.Subsequently, the patient was evaluated approximately twelve years post-implantation due to knee pain, inability to bear weight, swelling, warmth, and decreased range of motion associated with fevers, chills, poor appetite, and fatigue.Radiograph imaging noted joint effusions.The plan determined was for hospital admission, pain medication, and right knee aspiration.No further details or results are available at this time.

Event Description

No additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The reported event was confirmed via review of the provided medical records.No product was returned, or pictures provided.The provided medical records were reviewed by a healthcare professional and identified knee pain, inability to bear weight, fevers and rigors, poor appetite and fatigue, swollen knees with warmth, decreased range of motion and joint effusions.No history of gout or systemic inflammatory conditions identified.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause could not be determined.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: STEMMED TIBIAL COMPONENT PRECOAT SIZE 6
• Type of Device: 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: 17780292
• MDR Text Key: 323824161
• Report Number: 0002648920-2023-00220
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K933785
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2021
• Device Model Number: N/A
• Device Catalogue Number: 00598004702
• Device Lot Number: 61835157
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/25/2023
• Initial Date FDA Received: 09/20/2023
• Supplement Dates Manufacturer Received: 12/21/2023
• Supplement Dates FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Male