MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METAL CR MONOBLOCK TIBIAL COMPONENT: BLUE, SIZE 7 C-H, 12MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Pain (1994); Limited Mobility Of The Implanted Joint (2671)
Date of Event	04/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical product(s): associated products : item#:42502606802; femur cemented cruciate retaining (cr) standard right size 10 lot#:63932153.Item#:42540000038; all poly patella cemented 38 mm diameter; lot#:63950014.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is still implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3007963827 - 2020 - 00138, 0002648920 - 2020 - 00254.Remains implanted.
Event or Problem Description
It has been reported bilateral total knee arthroplasties performed approximately two years ago.At the one year postop visit, the patient reported moderate pain, stiffness with sitting, and some instability in the right knee.No intervention or treatment has been given, and the patient remains satisfied.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, g4, g7, h1, h2, h3, h6, h10.No product was returned as it remains implanted.Visual and dimensional evaluations could not be performed.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Office notes (from (b)(6)2018 to (b)(6) 2019) provided per crf report state that patient had pain, limited rom, instability and trouble in activity of daily living and difficulty ambulating.Radiographs were not sent for review due to poor photographic quality.Root cause cannot be determined from the information available.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: TRABECULAR METAL CR MONOBLOCK TIBIAL COMPONENT: BLUE, SIZE 7 C-H, 12MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 10029893
• Report Number: 3005751028-2020-00062
• Device Sequence Number: 19490283
• Product Code: JWH
• UDI-Device Identifier: 00889024310179
• UDI-Public: (01)00889024310179
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K012866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2020

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: 05/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 00588604712
• Device Lot Number: 63335016
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/13/2020
• Supplement Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 05/06/2020
• Supplement Report FDA Received Date: 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 135