MAUDE Adverse Event Report: ENCORE MEDICAL L.P. BIPOLAR HIP; SHELL, BIPOLAR, MODULAR, ENCORE, SIZE48

Model Number 412-02-048

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Laxity (4526)

Event Date 10/03/2022

Event Type  Injury  

Event Description

Revision surgery - foundation bipolar was implanted.Revision due to superior wear of the aceatabulum.

Manufacturer Narrative

The reason for this revision surgery was reported as wear.The previous surgery and the surgery detailed in this event occurred 3.5 months apart.The possible in-vivo time for the main item is 21 years apart from primary surgery.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.This investigation is limited in scope as only partial information was provided to djo surgical for review.The revised items were not returned for examination and the main item lot number was not provided.To adequately investigate this event, the lot number is necessary.Given the limited information, a search for the invoice (of the primary surgery) produced no results, therefore; the device history record of the main item could not be reviewed.If this information is submitted at a future date, this investigation will be re-evaluated.Djo biolox head and sleeve: 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 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.

Manufacturer Narrative

Implanted date (d.6a): 2001, the exact time cannot be determined.Manufacturer narrative: the reason for this revision surgery was reported as wear.The previous surgery and the surgery detailed in this event occurred 3.5 months apart.The time in vivo for the main item is possibly 21 years but without the 2001 d ticket/invoice, the exact time cannot be determined.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.This investigation is limited in scope as only partial information was provided to djo surgical for review.The revised items were not returned for examination and the main item lot number was not provided.To adequately investigate this event, the lot number is necessary.Given the limited information, a search for the invoice (of the primary surgery) produced no results, therefore; the device history record of the main item could not be reviewed.If this information is submitted at a future date, this investigation will be re-evaluated.Djo biolox head and sleeve: 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 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, SIZE48
• 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: 15634085
• MDR Text Key: 302024477
• Report Number: 1644408-2022-01360
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00888912077392
• UDI-Public: (01)00888912077392
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 412-02-048
• Device Catalogue Number: 412-02-048
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 400-04-280 LOT 881B1076A.; 400-05-004 LOT 887B1120.
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 64 KG