MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD 360 DISTAL FEMORAL AUGMENT 67.5X5 RL/LM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-03246, 0001825034-2021-03247, 0001825034-2021-03248, 0001825034-2021-03381, 0001825034-2021-03383, 0001825034-2021-03384, and 0001825034-2021-03385.Concomitant medical devices: vanguard ssk 360 femur l 67.5 catalog#: 185285 lot#: 3800175.Vanguard ssk psc tibial bearing 12x71/75 catalog#: 183882 lot#: 082250.Biomet 360 tibial tray 71mm catalog#: 185203 lot#: 142500.Vanguard 360 distal femoral augment 67.5x10 ll/r catalog#: 185405 lot#: 607240.Biomet 360 tibial sm cruciate wing catalog#: 185650 lot#: 017640.Biomet splined knee stem v2 15x160 catalog#: 148329 lot#: 836220.Biomet splined knee stem v2 15x120 catalog#: 148318 lot#: 698830.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.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 that patient is experiencing pain, swelling, loss of range of motion, instability, difficulty ambulating, and falling due to her knee locking up approximately 18 months post-implantation.No revision procedure has been reported.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: b4, b7, g3, g6, h2, and h10.
Event or Problem Description
No further event information available at the time of this report.
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.The reported event of pain could not be confirmed and therefore this complaint cannot be confirmed.Medical records were provided and reviewed by a health care professional.Review found increased pain and swelling and rom 0-110 degrees, no instability, no complications on xray, surgeon states increased pain is likely due to increased activity.Next follow up found walking with walker, no redness, minimal swelling, rom 0-110 degrees, no instability, continue with exercises.One month follow up found patient walks with walker, minimal swelling, rom 0-110 degrees, mild to moderate soft tissue tenderness over pes bursa proximal tibia, no complications on xray, diagnosed with local hamstring tendonitis / pes bursitis, given topical lidoderm patch.Patient fell straight back to due her knee locking up.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: VANGUARD 360 DISTAL FEMORAL AUGMENT 67.5X5 RL/LM
• 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: 13052276
• Report Number: 0001825034-2021-03382
• Device Sequence Number: 19808863
• Product Code: JWH
• UDI-Device Identifier: 00880304482265
• UDI-Public: (01)00880304482265(17)281207(10)726510
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K143192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 185305
• Device Lot Number: 726510
• 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: 12/15/2021
• Supplement Date Received by Manufacturer: 01/04/2022; 03/28/2022
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 01/30/2022; 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2018
• 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: Other
• Patient Sex: Female
• Patient Weight: 87 KG
• Patient Race: White