MAUDE Adverse Event Report: ZIMMER TMT TM CRUCIATE RETAINING MONOBLOCK TIBIAL COMPONENT; TM MONOBLOCK TIBIAL COMPONENT

Model Number N/A

Device Problems Material Erosion (1214); Fracture (1260); Loose or Intermittent Connection (1371); Metal Shedding Debris (1804); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); No Code Available (3191)

Event Date 10/17/2017

Event Type  Injury  

Manufacturer Narrative

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.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.

Event Description

It was reported that the patient underwent primary surgery on (b)(6) 2016 and a revision surgery on (b)(6) 2017 due to metallosis and loosening/infection.Stage one revision revealed a loose tibial with the medial tibial post sheared off at the base plate.Evidence of metallosis in joint tissue.Base plate removed and separated tibial post extracted.Femur still well fixed, but removed and replace with a cement spacer.Prosthesis sent to sterilising department for decontamination.Tm monoblock tibia is the only tmt design controlled part.

Manufacturer Narrative

No device was returned for evaluation, therefore only a device history review was performed.Device history records were reviewed for the component and no deviations or anomalies were found.It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.X-rays were provided, x-ray study showed particulate matter in the joint space, however there is no evidence to support the origin of the metallosis and sheared post.No further information was made available to support investigation.A definitive root cause for the reported event could not be determined with the information available.Should additional information be obtained to further this investigation, this report shall be updated.

Event Description

It was reported patient presented for a total knee arthroplasty revision approximately fifteen (15) months post-primary procedure due to pain and apparent tibial subsidence noted on radiographs.During the revision, a loose tibial component was noted, with particulate in the joint, metallosis, and a sheared off tibial post.All components were removed and cement spacers were placed.No further event information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The reported event was able to confirmed by review of the provided images.Visual examination found the peg of the tibial tray fractured off and metal debris on the articular surface.A review of the device history records was unable to be performed as the lot number was not provided.A definitive root cause was unable to 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: TM CRUCIATE RETAINING MONOBLOCK TIBIAL COMPONENT
• Type of Device: TM MONOBLOCK TIBIAL COMPONENT
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 7024524
• MDR Text Key: 91812921
• Report Number: 3005751028-2017-02732
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: PK031462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• 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: 00588604312
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 80