MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD SSK PSC TIB BRG 22X71/75 5 X 22; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Damage to Ligament(s) (1952); Pain (1994)
Date of Event	07/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Age at time of event: (b)(6).Concomitant medical product(s): 141620 971590 bmt splined knee stm 20x80; 183326 723820 vngd ssk intlk fmrl 70 lt; 4 unknown femoral augments; 141484 853700 biomet offset tibial tray 75mm; 141764 146600 biomet tib block 10mm 75; 141764 146600 biomet tib block 10mm 75.Report source: foreign country: (b)(6).Reported event was confirmed by review of medical records received.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: surgery was performed for explanation of knee stem.Intraoperative there was a disconnection between the tibia shaft and the tibia.Partial destruction of the proximal tibia was needed for explanation.Visual examination of the returned knee stem identified nicks, gouges, and marks consistent with wear and explantation.Other items returned included one vanguard femoral, 4 femoral augment blocks, one femoral bearing, one 2.5 mm adapter, one biomet offset tray tibia base, two maxim modular tibiae implants, four lock screws, one locking bar, one cap, two screws, and one screw.The device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-03208, 0001825034 - 2019 - 05798, 0001825034 - 2019 - 05800, 0001825034 - 2019 - 05802, 0001825034 - 2019 - 05803, 0001825034 - 2019 - 05804, 0001825034 - 2019 - 05806, 0001825034 - 2019 - 05807, 0001825034 - 2019 - 05808.
Event or Problem Description
It was reported patient underwent an initial left total knee arthroplasty on an unknown date with unknown product.Due to infection, the patient underwent a 2-stage revision with placement of a cement spacer on an unknown date.The patient later underwent removal of the cement spacer with placement of an ssk total knee system.Subsequently, the patient underwent removal of the ssk system due to persistent pain and chronic overloading of the collateral ligaments.All products were removed and competitor product placed.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: VNGD SSK PSC TIB BRG 22X71/75 5 X 22
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9531973
• Report Number: 0001825034-2019-05797
• Device Sequence Number: 14037188
• Product Code: JWH
• UDI-Device Identifier: 00880304440869
• UDI-Public: (01)00880304440869
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/30/2019

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: 08/08/2022
• Device Model Number: N/A
• Device Catalogue Number: 183892
• Device Lot Number: 482410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 12/30/2019
• 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: Hospitalization; Required Intervention