MAUDE Adverse Event Report: ENCORE MEDICAL L.P. BIPOLAR HIP; SHELL, BIPOLAR, MODULAR, ENCORE, SIZE53

Model Number 412-02-053

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 04/06/2022

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery was reported as infection.The previous surgery and the surgery detailed in this event occurred 2 months and 1 week 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 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 of 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 an infection.There were no findings during this evaluation that indicate the reported devices were the source or had a direct connection with the patient's infection.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 possible infection or inhibited the patient's immune system.There are multiple factors that may contribute to an infection that are outside the control of djo surgical.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.

Event Description

Revision surgery - due to infection, revision of hemi was done.Removed and exchanged out the bipolar and head.

• Brand Name: BIPOLAR HIP
• Type of Device: SHELL, BIPOLAR, MODULAR, ENCORE, SIZE53
• 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: 14188551
• MDR Text Key: 289896199
• Report Number: 1644408-2022-00526
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00888912077446
• UDI-Public: (01)00888912077446
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2022

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: 412-02-053
• Device Catalogue Number: 412-02-053
• Device Lot Number: 001C1097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2022
• Initial Date FDA Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2019
• 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
• Treatment: 497-28-000 LOT 629C1656
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male