MAUDE Adverse Event Report: OMNILIFE SCIENCE INC. APEX KNEE; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	KC-40358
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) initial report: the device manufacturing records will be located and reviewed.Conclusions will be provided in a supplemental report.Additional information, such as operative notes, patient activity level, medical history and weight, if patient experienced any traunma and an update on the patient was requested in order to perform the investigation.If provided they will be summarized in a supplemental report.Note: the submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.This report is filed with the fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.
Event or Problem Description
Apex revision after approximatively 7 years due to instability (patient dislocated going upstairs).
Additional Manufacturer Narrative
A complaint was initiated for a patient who underwent a knee revision surgery on (b)(6) 2023.The original surgery date is on (b)(6) 2016.The reason for revision is reported instability/patella dislocation.During the revision, insert, patella and bolt were removed and replaced with new components.The complainant made no indication of any omnilife science device malfunction or deficiency related to the identity, quality, durability, reliability, safety, effectiveness or device performance contributing to the adverse event.According to the intake form, the products are not available for return and evaluation.Review of the manufacturing documentation and sterilization documentation for the devices in question revealed no deviation from process or non-conformity of product that would have caused or contributed to the adverse event.Below is a summary of the documentation investigation: ref: kc-40358 patella lot number: 23811, date of manufacture: 06/30/2016, date of expiration: 06/30/2021, sterile batch: ols164047, ref: kc-20410 tibial insert size 4 ,10mm lot number: 20617, date of manufacture: 06/30/2015, date of expiration: 06/30/2020, sterile batch: ols154044, ref: kp-20010 retaining bolt lot number: 21967, date of manufacture: 10/31/2015, date of expiration: 10/31/2020, sterile batch: ols154088 cause cannot be determined.Revision surgeries have many variables including numerous patient conditions that contribute to the event taking place.No action was taken as a result of this complaint.This report is filed with the fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.

• Brand Name: APEX KNEE
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): OMNILIFE SCIENCE INC.; 480 paramount drive; raynham MA 02767
• Manufacturer (Section G): OMNILIFE SCIENCE INC.; 480 paramount drive; raynham MA 02767
• Manufacturer Contact: jamie demedeiros ; 480 paramount drive; raynham, MA 02767
• MDR Report Key: 16681880
• Report Number: 1226188-2023-00099
• Device Sequence Number: 12759738
• Product Code: JWH
• UDI-Device Identifier: 00841690101970
• UDI-Public: 00841690101970
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K060192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: KC-40358
• Device Catalogue Number: KC-40358
• Device Lot Number: 23811
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/04/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2016
• 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: APEX BOLT - MODEL 20010 LOT 21967.; APEX PS INSERT SIZE 4 - MODEL KP-20410 LOT 20617.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 162 KG