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

Model Number	412-01-056
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Event or Problem Description
Revision surgery - conversion from bipolar to total hip.
Additional 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
• Common Device Name: SHELL, BIPOLAR, MODULAR, ENCORE SIZE56
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 10875539
• Report Number: 1644408-2020-01095
• Device Sequence Number: 17225693
• Product Code: KWY
• UDI-Device Identifier: 00888912077279
• UDI-Public: (01)00888912077279
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K953510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 497-28-035 LOT 631C1062; 497-28-035 LOT 631C1062
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR