MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 3D KNEE; TIBIA, STEMMED, POROUS SIZE6 L 3D

Model Number	335-01-106
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/13/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - the original surgeon put in too large of an implant size inside the patient which made the patient feel pain.The first surgery was 7 years ago.No records could be found for this patient for the past hospital or surgeon indicated below or the current hospital and surgeon.
Additional Manufacturer Narrative
The reason for this revision surgery was due to pain.The actual length of in-vivo for the products listed is unknown as the original surgery date was not provided or could be established.This complaint evaluation is limited in scope since the part associated with this investigation was not returned to djo surgical for evaluation.The complaint reported no surgical delays during the revision surgery and the surgery was completed as intended without incident.A review of the device history records (dhr) was not conducted since the lot numbers were not provided or determined during the complaint evaluation.No information submitted with the complaint that would indicate a material, design, or manufacturing issue(s) with the explanted part.Extensive searches of the database and individual delivery tickets produced no matches of these parts or a delivery ticket.The root cause of this complaint was a revision surgery due to pain.Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: 3D KNEE
• Common Device Name: TIBIA, STEMMED, POROUS SIZE6 L 3D
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7151043
• Report Number: 1644408-2017-01222
• Device Sequence Number: 853880
• Product Code: JWH
• UDI-Device Identifier: 00888912115650
• UDI-Public: (01)00888912115650
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K020114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2018

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: 335-01-106
• Device Catalogue Number: 335-01-106
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 12/28/2017
• Supplement Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 010-55-025; 010-55-025; 010-55-025; 010-55-025; 236-01-106; 391-09-606
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR