MAUDE Adverse Event Report: ENCORE MEDICAL L.P X-ALT HIP; HEAD, FEMORAL, COCR, 40MM, +8MM

Model Number	400-00-404
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	04/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Third revision surgery - the patient was revised due to joint instability / multiple dislocations.Surgeon did not replace the removed implants.
Additional Manufacturer Narrative
Manufacuturer narrative: the reason for this revision surgery was reported as instability or dislocation.The previous surgery and the surgery detailed in this event occurred 11 days 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 and showed no non-conforming material reports (ncmr) associated with the main component listed in the complaint.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 instability or dislocation.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.Due to short time between previous and revision surgery, it is possible that the event may have occurred due to lack of post-operative care, patient noncompliance with medical instructions or incorrect implant selection, patient activities or trauma.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: X-ALT HIP
• Common Device Name: HEAD, FEMORAL, COCR, 40MM, +8MM
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 11852794
• Report Number: 1644408-2021-00465
• Device Sequence Number: 1021086
• Product Code: LPH
• UDI-Device Identifier: 00190446308416
• UDI-Public: (01)00190446308416
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072154
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2026
• Device Model Number: 400-00-404
• Device Catalogue Number: 400-00-404
• Device Lot Number: 554Z1001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 425-96-011 LOT 190R2084; 940-00-015 LOT 144Z1035; 940-00-020 LOT 145Z1018; 940-00-035 LOT 148Z1027; 940-00-035 LOT 148Z1049; 940-00-035 LOT 148Z1052; 940-00-045 LOT 150Z1011; 940-00-045 LOT 150Z1023; 940-00-045 LOT 150Z1025; 940-00-045 LOT 150Z1025; 940-03-56H LOT 817Z1002; 941-01-40H LOT 605Z1002
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR