MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. SL-PLUS AND SLR-PLUS; HEAD, FEMORAL, COCR 28/+7MM

Model Number	497-28-700
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was reported as dislocation.The previous surgery and the revision detailed in this investigation occurred 1 month and 3 weeks apart.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.Initial or prolonged hospitalization was required.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 (dhr) shows that the reported components 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 respective 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 device was verified to have gone through an acceptable sterilization process and was within it's expiration date at the time of use during the previous surgery.The root cause of this complaint was a revision surgery due to the dislocation.There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the patient event.There are multiple factors that may contribute to the event that are outside the control of djo surgical are patient activities, degenerative bone disease, patient bone deterioration, inadequate soft tissue, excessive range-of-motion, excessive load or trauma.No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any activities that may have contributed to the event and hence a definitive root cause cannot be determined.There are no indications of a product or process issue affecting implant safety or effectiveness.
Event or Problem Description
Revision surgery -patient has dislocation so surgeon put in a locking liner and change head.

• Brand Name: SL-PLUS AND SLR-PLUS
• Common Device Name: HEAD, FEMORAL, COCR 28/+7MM
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin texas 78758
• MDR Report Key: 8853199
• Report Number: 1644408-2019-00712
• Device Sequence Number: 11445741
• Product Code: JDI
• UDI-Device Identifier: 00888912087292
• UDI-Public: (01)00888912087292
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2019

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 Expiration Date: 02/11/2022
• Device Model Number: 497-28-700
• Device Catalogue Number: 497-28-700
• Device Lot Number: 635C1134
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 08/01/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 77 YR