MAUDE Adverse Event Report: ENCORE MEDICAL L.P BIPOLAR HIP; SHELL, BIPOLAR, MODULAR, ENCORE, SIZE44

Model Number 497-28-000

Device Problems Unstable (1667); Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Date 11/03/2020

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 - revision/ conversion of a bipolar hip to a total due to instability.

Manufacturer Narrative

Corrected data: see section d1., d2., d4., d10., & g4.Manufacturer narrative: the reason for this revision surgery was reported as instability.The actual length of in-vivo for the items listed is unknown as the original surgery date was not provided or could be established.The healthcare professional indicated there was significant adverse event to the patient.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.This investigation is limited in scope as only partial information was provided to djo surgical.The revised items was not returned for examination and the lot numbers was not provided.To adequately investigate this event, the part and lot numbers are necessary.If this information is submitted at a future date, this investigation will be re-evaluated.Customer complaint history of the reported items 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.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.The surgeon performed this revision to remedy the patient's condition.This complaint will be closed pending receipt of additional information.No further action is deemed necessary at this time.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

Manufacturer Narrative

Manufacturer narrative: the reason for this revision surgery was reported as instability.The actual length of in-vivo for the items listed is unknown as the original surgery date was not provided or could be established.The healthcare professional indicated there was significant adverse event to the patient.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.This investigation is limited in scope as only partial information was provided to djo surgical.The revised items were not returned for examination and the lot numbers were not provided.To adequately investigate this event, lot numbers are necessary.Given the limited information, a search for an invoice (of the previous surgery) could not be conducted, therefore; the items removed could not be identified.If this information is submitted at a future date, this investigation will be re-evaluated.Customer complaint history of the reported items showed no present trends or on-going issues that are needing a review.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.The surgeon performed this revision to remedy the patient's condition.This complaint will be closed pending receipt of additional information.No further action is deemed necessary at this time.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, SIZE44
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin,tx 78758-5445
• MDR Report Key: 10928550
• MDR Text Key: 218982666
• Report Number: 1644408-2020-01108
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00888912087254
• UDI-Public: (01)00888912087254
• 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,Followup
• Report Date: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 497-28-000
• Device Catalogue Number: 412-02-044
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 412-02-044 LOT UNKNOWN; 497-28-000 LOT UNKNOWN; 412-02-044 LOT UNKNOWN
• Patient Outcome(s): Other; Required Intervention