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

Model Number 497-28-000

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 03/22/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer narrative: additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

Event Description

Revision surgery - due to dislocation.Did a head and poly exchange.

Manufacturer Narrative

Corrected data: manufacturer narrative: the reason for this revision surgery was reported as dislocation.The previous surgery and the surgery detailed in this event occurred 10 years apart.The healthcare professional indicates there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The devices were disposed of at hospital and not made available to djo surgical for examination.A review of the device history records (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements and showed no non-conforming material reports (ncmr) associated with the main contributor component listed in the complaint.The devices were verified to have gone through an acceptable sterilization process and were within its expiration date at the time of the previous surgery.Customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to dislocation.There were no findings during this evaluation that indicate the reported devices were defective.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.There are multiple factors that may also contribute to an event that are outside the control of djo surgical such as poor bone density, patient bone deterioration, patient activities or trauma.There are no indications of a product or process issue affecting implant safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: SL-PLUS AND SLR-PLUS HIP
• Type of Device: HEAD, FEMORAL , COCR 28MM NEUTRAL
• Manufacturer (Section D): ENCORE MEDICAL L. P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 11704417
• MDR Text Key: 246655203
• Report Number: 1644408-2021-00345
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00888912087254
• UDI-Public: (01)00888912087254
• Combination Product (y/n): N
• PMA/PMN Number: K932481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/01/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: 497-28-000
• Device Catalogue Number: 497-28-000
• Device Lot Number: 629C1020
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/22/2021
• Initial Date FDA Received: 04/21/2021
• Supplement Dates Manufacturer Received: 05/06/2021
• Supplement Dates FDA Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 433-28-205, LOT 53812674
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR