MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. 3DKNEE; FEMUR, NONPOROUS, 3D, SIZE12, LT

Model Number 233-01-112

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Fall (1848)

Event Date 04/28/2017

Event Type  Injury  

Event Description

Second revision surgery - due to the patient falling and was not wearing his brace.He tore his medial collateral ligament (mcl) and the surgeon determined a revision would be the best course of action.

Manufacturer Narrative

The reason for this revision surgery was due to a torn medial collateral ligament (mcl).The previous surgery and the revision detailed in this investigation occurred over 8 months apart.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 implant device history records (dhr) shows that the reported components used in the previous surgery met design and manufacturing requirements.There was a non-conforming material reports (ncmr) # (b)(4) associated with the part 233-01-112, 3d knee cemented femoral component, size 12, which documents a non-conformance that out of (b)(4) quantity lot (b)(4) items were rejected due to out of tolerance features in anterior-posterior box geometry and these parts were sent to supplier to bend within specification.After these were reworked with suitable solution, (b)(4) of the rejected items were accepted and 1b)(4) rejected item was scrapped.In total, (b)(4) out of (b)(4) items in the lot were accepted.The device was within its expiration date at the time of use during the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to torn mcl.The root cause of the torn mcl was reported as a fall; and the patient was not wearing their brace.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: 3DKNEE
• Type of Device: FEMUR, NONPOROUS, 3D, SIZE12, LT
• 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: 6595887
• MDR Text Key: 76124173
• Report Number: 1644408-2017-00382
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00888912111188
• UDI-Public: (01)00888912111188
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: 233-01-112
• Device Catalogue Number: 233-01-112
• Device Lot Number: 897A1095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2015
• 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: 63 YR