MAUDE Adverse Event Report: ENCORE MEDICAL L.P FMP HIP; LINER, LOCKING RING, CONSTRAINED

Model Number 436-28-007

Device Problems Defective Component (2292); Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Date 12/10/2020

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

Second revision surgery - the constrained locking ring failed.Surgeon cemented in a stryker constrained liner and changed head to a 22 mm.

Manufacturer Narrative

Manufacturer narrative: the reason for this revision surgery was reported as constrained locking ring failure.The previous surgery and the surgery detailed in this event occurred 2 years and 11 months apart.Initial or prolonged hospitalization was required.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.There was a ncmr#33617 associated with the main part #436-28-007, liner, acetabular, fmp constrained 28xmp7, which documents that out of 10 parts lot, one parts was rejected and scrapped due to out of dimension.All other item in their respective lot have met with fit, form and functional requirement.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 constrained locking ring failure.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 djo surgical such as poor bone density, patient bone deterioration, inadequate 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 as soon as it becomes available.

Manufacturer Narrative

The reason for this revision surgery was reported as constrained locking ring failure.The previous surgery and the surgery detailed in this event occurred 2 years and 11 months apart.Initial or prolonged hospitalization was required.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.There was a non-conformance associated with the main part number 497-28-000, head, femoral,cocr 28mm neutral which documents that out of 20 parts lot, one part was rejected and scrapped due to scratches.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 constrained locking ring failure.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 djo surgical such as poor bone density, patient bone deterioration, inadequate 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 as soon as it becomes available.

• Brand Name: FMP HIP
• Type of Device: LINER, LOCKING RING, CONSTRAINED
• 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: kiersten soderman ; 9800 metric blvd; austin 78758-5445
• MDR Report Key: 11133588
• MDR Text Key: 225724724
• Report Number: 1644408-2020-01235
• Device Sequence Number: 1
• Product Code: KWZ
• UDI-Device Identifier: 00888912085700
• UDI-Public: (01)00888912085700
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2023
• Device Model Number: 436-28-007
• Device Catalogue Number: 436-28-000
• Device Lot Number: 496C1068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2017
• 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: 436-28-000 LOT 496C1068.; 436-28-007 LOT 499C1010.; 497-28-000 LOT 629C1352.; 497-28-000 LOT 629C1352.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female