MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL HINGE SERVICE KIT XT SIZE C USE WITH DISTAL FEMORAL XT SIZE C; PROSTHESIS, KNEE

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Damage to Ligament(s) (1952); Joint Dislocation (2374)

Event Date 01/26/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign - australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Multiple mdr reports were filed for this event: 0001822565-2023-00384.

Event Description

It was reported that the patient was revised approximately 2.5 years post implantation due to dislocation while getting up from a chair.It was noted that the extensor mechanism was compromised.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6: proposed component (annex g) code is mechanical (g04) - femur.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: dislocation of the implant, no signs of loosening wear, radiolucency, or other contributing factors.A definitive root cause cannot be determined.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 Description

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

• Brand Name: FEMORAL HINGE SERVICE KIT XT SIZE C USE WITH DISTAL FEMORAL XT SIZE C
• Type of Device: PROSTHESIS, 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: 16371763
• MDR Text Key: 309484875
• Report Number: 0001822565-2023-00383
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00889024196322
• UDI-Public: (01)00889024196322(17)280331(10)64667729
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K150028
• 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: 05/30/2023

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00585007113
• Device Lot Number: 64667729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/26/2023
• Initial Date FDA Received: 02/14/2023
• Supplement Dates Manufacturer Received: 05/30/2023
• Supplement Dates FDA Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2020
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female