MAUDE Adverse Event Report: ENCORE MEDICAL L.P. BIPOLAR HIP; SHELL, BIPOLAR, MODULAR, ENCORE SIZE56

Model Number 412-01-056

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 10/22/2020

Event Type  Injury  

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

Event Description

Revision surgery - conversion from bipolar to total hip.

Manufacturer Narrative

The reason for this revision surgery was reported, as conversion from bipolar to total hip.The previous surgery and the surgery detailed in this event occurred (b)(6) years and (b)(6) 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 (b)(6) 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 reported, as conversion from bipolar to total hip.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 (b)(6) surgical, such as poor bone density, patient bone deterioration, in adequate 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: BIPOLAR HIP
• Type of Device: SHELL, BIPOLAR, MODULAR, ENCORE SIZE56
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 10875539
• MDR Text Key: 217365867
• Report Number: 1644408-2020-01095
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00888912077279
• UDI-Public: (01)00888912077279
• Combination Product (y/n): N
• PMA/PMN Number: K953510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

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: 09/30/2017
• Device Model Number: 412-01-056
• Device Catalogue Number: 412-01-056
• Device Lot Number: 977B1012
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 02/01/2021
• Supplement Dates FDA Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 497-28-035 LOT 631C1062; 497-28-035 LOT 631C1062
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR