MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION HIP; HEAD, FEMORAL 32/+4

Model Number	400-32-400
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/19/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the patient dislocating.The revision surgery was required to place a more constrained liner option.The representative indicated he did not know anything about the first surgery, other than it was at the same hospital and different doctor.He was not able to get a first surgery date.The implant lot number is not pulling up any history in our database either so there is nothing on the first surgery.
Additional Manufacturer Narrative
The reason for this revision surgery was due to the patient dislocating.The length of in-vivo service is unknown since an original surgery date was not provided or could be established.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.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 disposed of at the hospital and not made available to djo surgical for examination.A review of the implant device history records (dhrs) show 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.Given the limited information, extensive search for an invoice of the previous surgery produced no results.Should additional information become available this investigation will be re-opened for further evaluation.The root cause of this complaint was a revision surgery due to the patient dislocating.Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: FOUNDATION HIP
• Common Device Name: HEAD, FEMORAL 32/+4
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7152543
• Report Number: 1644408-2017-01236
• Device Sequence Number: 19029110
• Product Code: JDI
• UDI-Device Identifier: 00888912076401
• UDI-Public: (01)00888912076401
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K932481
• 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): 02/16/2018

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: 06/28/2010
• Device Model Number: 400-32-400
• Device Catalogue Number: 400-32-400
• Device Lot Number: 214512
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/19/2017
• Supplement Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 12/28/2017
• Supplement Report FDA Received Date: 02/16/2018
• 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: 66 YR