MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR HIP; EMPOWR ACETABULAR SYSTEM, LINER, NEUTRAL, HXE+, 36F

Model Number 941-01-36F

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

Patient Problem Insufficient Information (4580)

Event Date 02/22/2022

Event Type  Injury  

Event Description

Revision surgery - surgeon revised due to instability and possible loose stem.

Manufacturer Narrative

The reason for this revision surgery was reported as instability and loosening.The previous surgery and the surgery detailed in this event occurred 2 years and 1 month 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 device was disposed of at hospital and not made available to djo surgical for examination.A review of the device history record (dhr) shows that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There was an ncmr# (b)(4) associated with the main part # 941-01-36f, empowr acetabular system, liner, neutral, hxe+, 36f which documents that out of (b)(4) parts lot, 1 part was rejected due to missing engraving per print.Later the rejected part was return to vendor.There was an another ncmr# (b)(4) associated with the same part which documents that out of (b)(4) parts lot, 1 part was rejected and scrapped due to missing engraving per print.All other items in the respective lot were met with fit, form and function requirements.The device was verified to have gone through an acceptable sterilization process and was 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 instability and loosening.There were no findings during this evaluation that indicate the reported device was 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, inadequate soft tissue support, 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: EMPOWR HIP
• Type of Device: EMPOWR ACETABULAR SYSTEM, LINER, NEUTRAL, HXE+, 36F
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 13775076
• MDR Text Key: 287245328
• Report Number: 1644408-2022-00317
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00190446309529
• UDI-Public: (01)00190446309529
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/15/2022

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 Model Number: 941-01-36F
• Device Catalogue Number: 941-01-36F
• Device Lot Number: 598Z1007
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/23/2022
• Initial Date FDA Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female