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

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Joint Dislocation (2374)
Date of Event	06/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical products: femoral component catalog # 00576401651, lot # 63957556.Inset all poly patella catalog # 00597206526, lot # 64545028.Stemmed tibial component catalog # 00598003702, lot # 63977204.Report source: (b)(6).Customer has indicated that the product will not be returned because requested but not returned by hospital.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 3007963827-2021-00146.
Event or Problem Description
It was reported that the patient underwent a knee arthroplasty.Subsequently, the patient was revised due to dislocating their femur and falling.Attempt for further information has been made, but no further information has been provided.
Event or Problem Description
From additional information received, it was reported that the patient noncompliance and obesity are contributing factors to the fall.The reason for the fall remains unknown.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.Updated: b4, b5, g3, g6, h1, h2.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays provided.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.X-ray review indicates there is marked anterior subluxation/near dislocation of the femur in relation to the tibia.No fracture is identified.Anterior soft tissue air and swelling and skin staples are present from recent surgery.Implant fit is maintained but there is abnormal anterior subluxation/near dislocation of the femur.Bone quality is osteopenic.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: ARTICULAR SURFACE PROLONG LPS-FLEX NEXGEN
• Common Device Name: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12216705
• Report Number: 0001822565-2021-01902
• Device Sequence Number: 16837127
• Product Code: JWH
• UDI-Device Identifier: 00889024211131
• UDI-Public: (01)00889024211131(17)240331(10)64316026
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 00596203210
• Device Lot Number: 64316026
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 08/27/2021
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 08/25/2021; 08/31/2021
• 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: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 126