MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E1 VNGD PS TIB BRG 71/75X10; PROSTHESIS, KNEE

Model Number	EP-183640
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)
Date of Event	10/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4): concomitant medical product: biomet ilok pri tib tray 71mm: catalog#141213, lot#384350; vngd ti fem ps 70mm rt: catalog#cp113642, lot#527780; biomet finned pri stem 40mm: catalog#141314; lot#267960; series a pat thn 34 3 peg: catalog#184786, lot#477690; palacos r 1x40 single: catalog#00111214001, lot#ni, qty#2.Multiple mdr reports have been filed for this event.Please see associated reports: 0001825034-2022-00924; 0001825034-2022-00926; 0001825034-2022-00927.Customer has indicated that product will not be returned to zimmer biomet for investigation, as the product has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported via a clinical study that a patient underwent an initial right total knee arthroplasty.Subsequently, ten months post implantation, the patient was revised due to pain, stiffness, swelling, clicking, and instability.A ct scan prior to the revision noted that the tibial component had internally rotated.During the procedure, the surgeon found that there was cement present on the bone and tibial implant, which was easily removed.The femoral implant had no cement attached.The patellar component was left intact but all other components were revised without complication.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Review found patient presented with pain, stiffness, swelling, clunking sensation, audible popping and moderate instability.Ct shows tibial component is internally rotated by 25-30 degrees.During the revision procedure the tibia was easily removed and no cement was noted on the femoral implant.No complications noted.A definitive root cause cannot be determined.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.

• Brand Name: E1 VNGD PS TIB BRG 71/75X10
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14166364
• Report Number: 0001825034-2022-00925
• Device Sequence Number: 20086432
• Product Code: JWH
• UDI-Device Identifier: 00880304465749
• UDI-Public: (01)00880304465749(17)231016(10)943800
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2022

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: 10/16/2023
• Device Model Number: EP-183640
• Device Catalogue Number: EP-183640
• Device Lot Number: 943800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2022
• Supplement Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 102 KG