MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION KNEE/ ULTRA CONGRUENT; INSERT, ULTRA CONGRUENT SIZE6 11MM CM

Model Number	380-11-506
Health Effect - Clinical Codes	Wound Dehiscence (1154); No Code Available (3191)
Date of Event	01/30/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the patient being presented with wound dehiscence (from a fall) two weeks post operation.The surgeon debrided the wound and swapped the poly.
Additional Manufacturer Narrative
The reason for this revision surgery was due to a wound dehiscence.The previous surgery and the revision detailed in this investigation occurred 14 days apart.There are no reported pre-existing patient health conditions.The healthcare professional indicated there was a significant adverse event to the patient.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 not made available to djo surgical for examination.A review of the implant device history records (dhr) shows that the reported component used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the event.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 a wound dehiscence.There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the event.The agent has clearly mentioned that the wound dehiscence happened due to the patient's fall, it seems that the event may have been occurred due to trauma, patient noncompliance with medical instructions or patient activities.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: FOUNDATION KNEE/ ULTRA CONGRUENT
• Common Device Name: INSERT, ULTRA CONGRUENT SIZE6 11MM CM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7259679
• Report Number: 1644408-2018-00117
• Device Sequence Number: 16438264
• Product Code: JWH
• UDI-Device Identifier: 00888912117135
• UDI-Public: (01)00888912117135
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K963028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2018

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 Expiration Date: 05/25/2022
• Device Model Number: 380-11-506
• Device Catalogue Number: 380-11-506
• Device Lot Number: 428B1034
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 02/09/2018
• Supplement Report FDA Received Date: 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 73 YR