MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN PERSONA FEMORAL PROVISIONAL; INSTRUMENT, KNEE

Model Number N/A

Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/20/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant has not yet indicated whether the product will 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.H3 other text : investigation incomplete.

Event Description

It was reported that while the surgeon was performing a total knee arthroplasty revision, it was identified that the patient's previous surgeon had cemented and implanted a femoral trial.It is not known whether the revision was performed due to complications from the trial or not.Attempts have been made; however, no additional information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

It was reported that during a first stage revision for infection, the surgeon implanted a femoral trial temporarily.The femoral trial was then removed during the second stage revision.Attempts have been made; however, no additional information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10 - concomitant devices - unknown persona articular surface catalog #: ni lot #: ni.H6: component code: mechanical (g04) - femur.Photographs provided identified that the trial and articular surface exhibited evidence of explantation (surgical suite background and surgical debris).The device history records could not be reviewed as the lot number associated with the reported event is unknown.The reported devices were determined to not be compatible.The root cause is attributed to an off-label issue.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.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001822565-2023-02829, 0001822565-2024-00312.

Event Description

No further event information available at the time of this report.

• Brand Name: UNKNOWN PERSONA FEMORAL PROVISIONAL
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17924133
• MDR Text Key: 325528051
• Report Number: 0001822565-2023-02829
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2024

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 10/12/2023
• Supplement Dates Manufacturer Received: 11/21/2023; 01/23/2024
• Supplement Dates FDA Received: 12/15/2023; 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose