MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METAL TIBIAL CONE, MEDIUM 46X34MM

Model Number	00-5450-013-46
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/14/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent right total knee arthroplasty.Subsequently, patient experienced strep g infection subsequent to cellulitis which began approximately four months post-implantation.Patient underwent a washout procedure with the polyethylene bearing exchanged.The infection continued and the patient underwent an arthroscopic washout procedure approximately one month later.Still, the infection continued; therefore, the patient underwent long-term antibiotic therapy utilizing vancomycin with no resolution of the infection.The patient subsequently underwent a washout procedure with revision of all implants and was implanted with antibiotic cement spacers.
Additional Manufacturer Narrative
Multiple report submitted for the same event : mfr report # 3005751028 - 2019 - 00008 (b)(4).Mfr report # 3005751028 - 2019 - 00007 (b)(4).Initial report 3005751028 - 2019 - 00008 was submitted by the error for (b)(4).This event is reported under mfr # 3005751028 - 2019 - 00007.All the follow up reports will be submitted under mfr # 3005751028 - 2019 - 00007.
Event or Problem Description
(b)(6) to remove lcck and tibial cone, washout and replace with cement spacers.

• Brand Name: TRABECULAR METAL TIBIAL CONE, MEDIUM 46X34MM
• Common Device Name: TRABECULAR METAL TIBIAL CONE, MEDIUM 46X34MM
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 8413125
• Report Number: 3005751028-2019-00008
• Device Sequence Number: 1278375
• Product Code: MBH
• UDI-Device Identifier: 00889024308299
• UDI-Public: (01)00889024308299(17)210228(10)63266339)
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K108296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2019

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: 02/28/2021
• Device Model Number: 00-5450-013-46
• Device Catalogue Number: 00545001346
• Device Lot Number: 63266339
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/01/2019
• Supplement Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 05/28/2019
• 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: Required Intervention
• Patient Weight: 99