MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. FOUNDATION KNEE; BASEPLATE, STEMMED, NON POROUS TIBIAL COCR SIZE6L

Catalog Number	323-01-106
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/11/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the patient having aseptic loosening.
Additional Manufacturer Narrative
The reason for this revision surgery was aseptic loosening.The length of in vivo service was 11.3 months.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 (b)(4) for examination.A review of the device history records showed 1 non-conforming material reports (ncmr) associated with this product.Nmcr (b)(4); boxes were wet, implants not affected, repackaged and approved for use.A review of the product complaint report history showed there have been (b)(4) prior complaints reported against this part number; summary of investigations: 4 infections, 1 broken or cracked, 2 instability, 2 pain.This is the first complaint against this lot number.This event is deemed to be non-product related.The root cause for aseptic loosening was not reported.The scope of this investigation is limited without having the parts available to (b)(4) for evaluation.Other conditions 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.

• Brand Name: FOUNDATION KNEE
• Common Device Name: BASEPLATE, STEMMED, NON POROUS TIBIAL COCR SIZE6L
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• MDR Report Key: 5341315
• Report Number: 1644408-2015-00781
• Device Sequence Number: 16203587
• Product Code: JWH
• UDI-Device Identifier: 00888912115094
• UDI-Public: (01)00888912115094
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K923277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Followup
• Report Date (Section B): 12/11/2015

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: 06/30/2020
• Device Catalogue Number: 323-01-106
• Device Lot Number: 219B1134
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/04/2016
• Supplement Report FDA Received Date: 06/02/2016
• 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: Required Intervention
• Patient Age: 47 YR