MAUDE Adverse Event Report: ENCORE MEDICAL L.P. ENCORE HIP; STEM, HIP, FEMORAL, LINEAR LATERAL SIZE13

Catalog Number 425-05-013

Device Problem Break (1069)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 11/17/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Revision surgery - due to metal on metal cup failure.The metal inert impinged onto the neck of the stem.This impingement, by mechanism of the patient ambulating, cut through the neck of the stem until the neck was cut through and broke.Also damaged was the liner.Djo cup remained in place.Stem and head were replaced with stryker.The metal on metal liner, metal head, and stem were removed.Also removed, was a significant amount of damaged tissue as a result of tiny metal and polyethylene fragments from these failed devices.

Manufacturer Narrative

Corrected data: see d.2.Manufacturer narrative: the reason for this revision surgery was reported as metal on metal cup failure.The previous surgery and the surgery detailed in this event occurred 16 years and 4 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 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 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 a revision surgery due to metal on metal cup 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.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: ENCORE HIP
• Type of Device: STEM, HIP, FEMORAL, LINEAR LATERAL SIZE13
• 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,tx 78758-5445
• MDR Report Key: 13018318
• MDR Text Key: 283935484
• Report Number: 1644408-2021-01402
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00888912078030
• UDI-Public: (01)00888912078030
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974294
• 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
• Report Date: 12/24/2021

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: 02/28/2011
• Device Catalogue Number: 425-05-013
• Device Lot Number: 239672
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2021
• Initial Date FDA Received: 12/16/2021
• Supplement Dates Manufacturer Received: 12/16/2021
• Supplement Dates FDA Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2005
• 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: 010-55-020 LOT 250662C; 411-00-350 LOT 243592; 497-38-000 LOT 259042; 499-38-009 LOT 254492A
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male