MAUDE Adverse Event Report: ENCORE MEDICAL L.P. X-ALT HIP; LINER, ACETABULAR, NON-HOODED, NEUTRAL, HXL/FMP, 40MM ID, MP9

Model Number 931-40-256

Device Problems Crack (1135); Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 02/17/2022

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery was reported as liner exchange and loose stem.The previous surgery and the surgery detailed in this event occurred 5.1 years 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 was 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 a liner exchange and loose stem.During the surgery the pelvis cracked after impaction, prompting the doctor to remove the cup and screws.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 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.

Event Description

Revision surgery: originally the liner was removed to put in a mp9 40mmid/5mm offset liner.During the impaction of that the pelvis has cracked.Surgeon then decided to remove the cup and 2 screws and replace it all with biomet.The clp stem was also removed with the original 40mm/-4 biopic head as the stem was loose causing dislocation.

• Brand Name: X-ALT HIP
• Type of Device: LINER, ACETABULAR, NON-HOODED, NEUTRAL, HXL/FMP, 40MM ID, MP9
• 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: 13684826
• MDR Text Key: 286726714
• Report Number: 1644408-2022-00301
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00888912099707
• UDI-Public: (01)00888912099707
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2020
• Device Model Number: 931-40-256
• Device Catalogue Number: 931-40-256
• Device Lot Number: 701F1085
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2015
• 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: 010-55-025 LOT 006A1264; 010-55-030 LOT 007A1163; 400-03-401 LOT 870B1065; 426-10-070 LOT 407N1027; 430-98-056 LOT 591G1157
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male