MAUDE Adverse Event Report: ENCORE MEDICAL L.P. SL-PLUS AND SLR-PLUS; HIP, STEM, CLP, STANDARD, SIZE#5, IMPLANT, POLISHED NECK

Model Number 426-10-050

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/16/2019

Event Type  Injury  

Event Description

Revision surgery - stem was loose so all implants were removed and replaced with stryker.

Manufacturer Narrative

The reason for this revision surgery was reported as loosening.The previous surgery and the surgery detailed in this event occurred 6 years and 10 months 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.The devices were disposed of at the 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.There were no non-conforming material reports (ncmr) associated with the products that may have contributed to the reported event.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 loosening.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 contribute to an event that are outside the control of djo surgical such as inadequate soft tissue support, excessive range of motion, poor bone density, degenerative bone disease, patient bone deterioration, patient activities or trauma.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: SL-PLUS AND SLR-PLUS
• Type of Device: HIP, STEM, CLP, STANDARD, SIZE#5, IMPLANT, POLISHED NECK
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 9193603
• MDR Text Key: 162451510
• Report Number: 1644408-2019-00983
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00888912079532
• UDI-Public: (01)00888912079532
• 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: 11/14/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: 426-10-050
• Device Catalogue Number: 426-10-050
• Device Lot Number: 405N1001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/16/2019
• Initial Date FDA Received: 10/15/2019
• Supplement Dates Manufacturer Received: 10/15/2019
• Supplement Dates FDA Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 400-03-362 LOT 866B1024.; 430-98-052 LOT 587G1012.; 931-36-252 LOT 690F1057.
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR