MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISTAL FEMORAL XT COMPONENT SIZE C RIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2022

Event Type  Injury  

Event Description

It was reported that a patient was revised approximately one year and eight months post implantation due to disassociation of the hinge pin and locking cap on the segmental distal femur.No further information is available.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2022-00539.Concomitant medical products: articular surface with segmental hinge post size c 14 mm height: item# 00585003014, lot# 63673429; polyethylene insert xt size c: item# 00585001396, lot# 64741569.Report source- (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2022-00539.Concomitant medical products: articular surface with segmental hinge post size c 14 mm height: item# 00585003014, lot# 63673429; polyethylene insert xt size c: item# 00585001396, lot# 64741569.Report source- (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient was revised approximately one year and eight months post implantation due to disassociation of the hinge pin and locking cap on the segmental distal femur.No further information is available.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot 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.

Event Description

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

• Brand Name: DISTAL FEMORAL XT COMPONENT SIZE C RIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13552350
• MDR Text Key: 285951080
• Report Number: 0001822565-2022-00538
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00889024195950
• UDI-Public: (01)00889024195950(17)280229(10)63900176
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 03/16/2022

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: 00585004302
• Device Lot Number: 63900176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/26/2022
• Initial Date FDA Received: 02/17/2022
• Supplement Dates Manufacturer Received: 03/10/2022
• Supplement Dates FDA Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2018
• 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): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 95 KG