MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METAL¿¢ PS MONOBLOCK TIBIAL COMPONENT: SIZE 4 E-F, 10MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Fall (1848)
Date of Event	09/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant associated products : item#:00587806529;nexgenâ® complete knee solution, trabecular metalâ¿¢ standard primary patella; lot#:64010413; item#:42500206002;femur trabecular metal posterior stabilized (ps) narrow porous ; lot#:63328805.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: 0001822565 - 2020 - 01646.Still implanted.
Event or Problem Description
It was reported that patient had initial right total knee arthroplasty performed approximately 10 months ago.Subsequently, the patient felt her knee give out resulting in a fall.The event was reported as resolved the same day.The patient sustained no injury, and no treatment/intervention was provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.A definitive root cause cannot be determined.Crf report states that there were no intra operative complications during implantation surgery.Patient slipped and fell down on (b)(6) 2019 and was resolved same day without treatment.On (b)(6) 2019, the patient felt her knees were giving out and she fell and was resolved on same day without treatment.On (b)(6) 2019, patient reported to have moderate pain with rom 0-110°, no abnormalities on x-ray, moderate trouble with adls, mild activities, dissatisfied.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional information at the time of this report.

• Brand Name: TRABECULAR METAL¿¢ PS MONOBLOCK TIBIAL COMPONENT: SIZE 4 E-F, 10MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 10030316
• Report Number: 3005751028-2020-00061
• Device Sequence Number: 16801596
• Product Code: JWH
• UDI-Device Identifier: 00889024310520
• UDI-Public: (01)00889024310520
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K020295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2020

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: 08/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00588606410
• Device Lot Number: 63703077
• 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: 06/05/2020
• Initial Report FDA Received Date: 05/06/2020
• Supplement Report FDA Received Date: 06/15/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 82