MAUDE Adverse Event Report: ENCORE MEDICAL L.P CLP HIP; HEAD, FEMORAL, COCR 28/+3.5MM

Model Number	497-28-350
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - dislocated.
Additional Manufacturer Narrative
The reason for this revision surgery was reported as dislocation.The previous surgery and the revision detailed in this investigation occurred over 11.6 years apart.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the event.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.Initial or prolonged hospitalization was required.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 device history records (dhr) was not conducted since the lot number was not provided or determined during the complaint evaluation.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 dislocation.Given the complaint history of the listed items (since a dhr review could not be conducted), there were no findings that indicate that the reported device was defective.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: CLP HIP
• Common Device Name: HEAD, FEMORAL, COCR 28/+3.5MM
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd.; 9800 metric blvd; austin,tx 78758-5445
• MDR Report Key: 8783109
• Report Number: 1644408-2019-00645
• Device Sequence Number: 1668736
• Product Code: JDI
• UDI-Device Identifier: 00888912024044
• UDI-Public: (01)00888912024044
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K932481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2019

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: 497-28-350
• Device Catalogue Number: 497-28-350
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 08/06/2019
• 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: 432-28-206 LOT UNKNOWN
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 83 YR