MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN LPS-MOBILE ARTICULAR SURFACE; PROSTHESIS KNEE

Model Number N/A

Device Problems Fracture (1260); Unstable (1667)

Patient Problem Failure of Implant (1924)

Event Date 10/09/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - medical product: all poly patella size 0 8 mm thickness catalog # 00542000800 lot # 62322901 fluted stem mob prct plt sz 6 catalog # 00591606001 lot # 62281197 femoral component option size e right compatible with lps-flex prolong catalog # 00596401552 lot # 62072148.Bone scr 6.5x35 self-tap catalog # 00625006535 lot # 62266784; bone scr 6.5x35 self-tap catalog # 00625006535 lot # 62363429; universal disposable drill and pin set 3 in pins(4), 5 in pin(1), 5 in drill(1) catalog # 200100000 lot # 62344203.H3: customer has indicated that the product will not be returned because it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : discarded.

Event Description

It was reported patient underwent a revision procedure seven years post implantation due to instability and implant fracture in knee.Attempts to obtain additional information have been made; however, no more is available.

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 was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.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 Description

No further event information available at the time of this report.

• Brand Name: NEXGEN LPS-MOBILE ARTICULAR SURFACE
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17490375
• MDR Text Key: 320699719
• Report Number: 0001822565-2023-02083
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024000674
• UDI-Public: (01)00889024000674(17)171231(10)62241771
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 00591705010
• Device Lot Number: 62241771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 91 KG