MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METAL¿¢ POSTERIOR STABILIZED MONOBLOCK TIBIAL COMPONENT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Pain (1994); Loss of Range of Motion (2032); Swelling (2091)
Date of Event	02/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: 00587806535, patella, lot # 63538625.42500806801, femoral component, lot # 63597279.Multiple mdr reports were filed for this event, please see associated reports: 3005751028-2019-00036.
Event or Problem Description
It was reported that approximately 2 years post implantation, the patient was revised due to pain, stiffness, instability, limited rom, and swelling.X-rays noted tibial cut was in significant varus.During the revision procedure, heterotopic ossification, poly wear, and loosening of the femoral component were noted.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
The reported event was confirmed by review of the provided medical records.The medical records identified that approximately 5 months post implantation, the patient began to experience pain due to playing golf frequently.Approximately 1 year post op, the patient had a fall and experienced pain and swelling.Office notes dated 3 months post fall demonstrated that the patient had antalgic gait for the left leg.X-ray review identified that the tibial component appeared to be in varus and surgeon noted tibial cut was in significant varus.Patient underwent a revision approximately 21 months post implantation due to pain.During the revision, the patella was found worn and the femoral component loose and heterotopic bone removed.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: TRABECULAR METAL¿¢ POSTERIOR STABILIZED MONOBLOCK TIBIAL COMPONENT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 9239584
• Report Number: 3005751028-2019-00037
• Device Sequence Number: 18870762
• Product Code: MBH
• UDI-Device Identifier: 00889024309814
• UDI-Public: (01)00889024309814
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K031462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 00588605712
• Device Lot Number: 62047573
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 03/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 102