MAUDE Adverse Event Report: ZIMMER TMT TM MONOBLOCK CR TIBIAL COMPONENT

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Loss of Range of Motion (2032)

Event Type  Injury  

Manufacturer Narrative

Investigation in progress.Device location unknown.

Event Description

On may 16 a journal article ¿superior fixation of pegged trabecular metal over screw-fixed pegged porous titanium fiber mesh¿ by maiken stilling et.Al a stating a prospective, parallel-group, randomized unblinded clinical trail study clinical study was conducted on tibial components.It was reported after 2 years of follow up that 1 patient with a tm monoblock cr tibial component reported pain at 2 years, had a stable implant (determined by rsa) but had reduced range of motion due to arthrofibrosis.That was treated by loosening of adherences under anesthesia.

Manufacturer Narrative

No device or photos were received; therefore the condition of the device is unknown.The lot number of the product is unknown; therefore the device history records, complaint history could not be reviewed.It could not be confirmed if the device was used in an approved and compatible combination.Surgical notes were not provided.It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Relevant medical history is unknown.Unsuccessful attempts were made to obtain additional information.No further details were made available.Based on the information available, the root cause of the event cannot be determined.Should additional information be obtained to further this investigation, this report shall be updated.

• Brand Name: TM MONOBLOCK CR TIBIAL COMPONENT
• Type of Device: TM MONOBLOCK CR TIBIAL COMPONENT
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer (Section G): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer Contact: william hara ; 10 pomeroy road; parsippany, NJ 07054 ; 9735760032
• MDR Report Key: 6644372
• MDR Text Key: 77710280
• Report Number: 3005751028-2017-00040
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: PK031462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/02/2017

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 Model Number: N/A
• Device Catalogue Number: TM MONOBLOCK CR TIBIA
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/16/2017
• Initial Date FDA Received: 06/15/2017
• Supplement Dates Manufacturer Received: 05/16/2017
• Supplement Dates FDA Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention