MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE USE WITH LPS/LPS-FLEX 51 OR 52 10 MM HEIGHT; PROSTHESIS, KNEE

Model Number	5962-22-10
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Dislocation (2374)
Date of Event	02/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an initial total knee arthroplasty.Subsequently, seven days post-implantation, the patient presented with pain and it was revealed that the articular surface had dislocated.The patient underwent revision surgery the next day to replace the bearing component.Due diligence is in progress for this complaint; to date no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: lps-flex option femoral d-l: catalog#00596401451, lot#65355645; ng ps mic pre st tib plt sz2: catalog#00598002702, lot#65521126.Report source: foreign: china.Customer has indicated that the product is in process of being returned to zimmer biomet for evaluation.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: a2; b4; b5; b7; g3; h2; h10.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial total knee arthroplasty.Subsequently, eight (8) days post-implantation, the patient presented with pain and it was revealed that the articular surface had dislocated.The patient underwent revision surgery the next day to replace the bearing component.Due diligence is in progress for this complaint; to date no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual inspection for the returned device found the locking features to be flared out and the proximal and distal surfaces show some damages.The device also exhibits damage nicked / gouged in various area.An intra operative video was provided and shows that the device has disassociated.Device history record was reviewed and no discrepancies related to the reported event were found.Primary operative notes state there were no intra-operative complications.X-ray images were assessed but not sent to mmi as the background of the or obscures the view of the implants in the x-rays.Sending the images would not enhance the investigation.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information at time of this report.

• Brand Name: ARTICULAR SURFACE USE WITH LPS/LPS-FLEX 51 OR 52 10 MM HEIGHT
• Common Device Name: 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: 16477416
• Report Number: 0001822565-2023-00571
• Device Sequence Number: 17973264
• Product Code: JWH
• UDI-Device Identifier: 00889024210905
• UDI-Public: (01)00889024210905(11)220909(17)270908(10)65486297
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2023

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 Model Number: 5962-22-10
• Device Catalogue Number: 00596202210
• Device Lot Number: 65486297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/08/2023
• Supplement Date Received by Manufacturer: 03/07/2023; 04/17/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 03/27/2023; 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2022
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female