MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VGXP XP E1 TIB BRG LM 9X63; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Cyst(s) (1800); Failure of Implant (1924)
Date of Event	01/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Foreign (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00264.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient had a total knee arthroplasty and subsequently was revised approximately 5 years after the initial procedure due to wear and fracture of the implant.Development of cysts was noted on medial tibia plateau.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4) this follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, d10, g4, g7, h1, h2, h6, h10.The complaint is confirmed.Visual examination of the returned product/provided pictures identified signs of being implanted wear / scratched / gouged and has cracked / fractured.Device was submitted for further analysis.Analysis identified some potential light wear, pitting, and/or abrasion consistent with in-vivo use.There is evidence of a possible crack on the posterior side of the bearing, partially separating a fragment of the item from the main body.There is no evidence of delamination or impingement near the possible crack.There are also some small gouges or scratches that are likely the result of explanation damage.There are also some small possible scratches and gouges on the lateral side that are likely explantation damage.The tibial tray was not returned.Review of the device history records identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: periprosthetic lucency noted surrounding at least 1 of the posterior tibial pegs indicative of loosening, suggested poly wear and loosening.A definitive root cause cannot 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: VGXP XP E1 TIB BRG LM 9X63
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11251713
• Report Number: 0001825034-2021-00280
• Device Sequence Number: 3606705
• Product Code: JWH
• UDI-Device Identifier: 00880304550278
• UDI-Public: (01)00880304550278(17)190714(10)874800
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K132873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

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: 07/14/2014
• Device Model Number: N/A
• Device Catalogue Number: 195877
• Device Lot Number: 874800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/22/2021
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 01/29/2021
• Supplement Report FDA Received Date: 03/23/2021
• 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: ITEM 195753 LOT 543250; TIBIAL TRAY ITEM UNKNOWN LOT UNKNOWN; TIBIAL TRAY ITEM UNKNOWN LOT UNKNOWN
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 68