MAUDE Adverse Event Report: ENCORE MEDICAL L.P. MOVATION KNEE; MOVATION TIBIAL INSERT, SIZE 4, 9MM VE, PRODUCT CODE:

Model Number 292-09-704

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/14/2016

Event Type  Injury  

Manufacturer Narrative

Corrected data: mfr report # was incorrect.Correct mfr report # 1644408-2016-00447.The reason for this revision surgery was the patient needed a thicker insert.The in-vivo length of service for the patient's implant was 1.4 years.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the device history records (dhrs) revealed no discrepancies or issues with the manufacturing history of this part.All parts were found to meet design and manufacturing specifications.No non-conforming material reports (ncmr's) were associated with this part.The product complaint report history was reviewed and no trends or on-going issues were deemed as present or in need of review.This event is deemed to be non-product related.The root cause for event was not reported.The surgeon reported no issues associated with the explanted product.The scope of this investigation is limited without having the parts available to djo surgical for evaluation.Other conditions, root cause, relating to this event could not be determined with confidence.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

Event Description

Revision surgery - due to the patient needing a thicker insert.

• Brand Name: MOVATION KNEE
• Type of Device: MOVATION TIBIAL INSERT, SIZE 4, 9MM VE, PRODUCT CODE:
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer Contact: teffany hutto ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 9203079
• MDR Text Key: 162810179
• Report Number: 1644408-2016-00447
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 00888912112390
• UDI-Public: (01)00888912112390
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 292-09-704
• Device Catalogue Number: 292-09-704
• Device Lot Number: 304N1005
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 91