MAUDE Adverse Event Report: ZIMMER TMT TM POSTERIOR STABILIZED MONOBLOCK TIBIAL COMPONENT; PROSTHESIS, KNEE

Model Number	00-5886-064-10
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Pain (1994); Loss of Range of Motion (2032); Swelling (2091)
Date of Event	12/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.The product was likely conforming when it left zimmer biomet control.The device is used for treatment.The reported product was reviewed for compatibility with no issues noted: part# 00588606410 lot # 63704833.Review of complaint history identified no additional similar complaints for the reported part and lot number combination.Complaints are monitored through monthly meeting in order to identify potential adverse trends.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified no intra-operative complication during the surgery.Six-week study notes found that the patient experiencing severe pain, moderate instability and difficulty in walking and day to day activities.This information confirmed the reported event.Per package insert , pi-021 rev k the nexgen complete knee solution/cruciate retaining (cr), legacy knee - posterior stabilized (lps) trabecular metal monoblock tibias : the pain, swelling, and instability are known adverse effects of this system.However, a definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.
Event or Problem Description
It was reported that a patient had a left tka and subsequently complains of pain, instability, altered gait, and aspiration (results pending).There is no additional information at this time.

• Brand Name: TM POSTERIOR STABILIZED MONOBLOCK TIBIAL COMPONENT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 9175757
• Report Number: 3005751028-2019-00034
• Device Sequence Number: 2692959
• Product Code: JWH
• UDI-Device Identifier: 00889024310520
• UDI-Public: (01)00889024310520(17)220930(10)53704833
• Combination Product (Y/N): N
• PMA/510(K) Number: K020295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 00-5886-064-10
• Device Catalogue Number: 00588606410
• Device Lot Number: 63704833
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2018
• Initial Report FDA Received Date: 10/10/2019
• 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: Other