MAUDE Adverse Event Report: ENCORE MEDICAL L.P TAPERFILL HIP STEM, LATERAL OFFSET, SIZE 9; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	425-97-009
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/02/2023
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
Revision surgery - due to patient presented with failed fixation of left hip fracture (3 cannulated screws) and was taken to surgery for conversion to left total hip on (b)(6) 2023.Case proceeded uneventfully, inter-op xrays showed components in optimal position, and upon completion of surgery patient was taken to recovery.Post-op xrays showed the acetabular component had moved slightly into pelvis.Patient was returned to surgery on (b)(6) 2023.
Additional Manufacturer Narrative
See d4 expiration date and h4.The reason for this revision surgery, the agent reported "(this patient had previously undergone radiation therapy in the area of his left hip.Patient presented with failed fixation of left hip fracture (3 cannulated screws) and was taken to surgery for conversion to left total hip.Case proceeded uneventfully, inter-op x-rays showed components in optimal position and upon completion of surgery patient was taken to recovery.Post-op x-rays showed the acetabular component had moved slightly into pelvis.Patient was returned to surgery, all components were removed, and a zimmer cup cage construct was implanted to restore acetabular integrity, a new taper fill stem and biolox head were implanted in the femur.Surgery was completed and patient was sent to recovery)".The previous surgery and the surgery detailed in this event occurred 2 days apart.This evaluation is limited in scope as the items associated with this investigation were not returned to djo surgical - austin for examination.The surgery was completed as intended and without incident.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.There were no findings during this evaluation that indicate the reported devices were defective.The surgeon performed this procedure to remedy the patient's condition.No further action is deemed necessary.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 nonconformance associated with the main part#: 425-97-009, taper fill hip stem, lateral offset, size 9, which documents that out of 12 parts lot, 2 parts were rejected and scrapped during dimensional inspection.All other items in the lot were met with the design, fit and function requirements.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 failed fixation of hip fracture.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, 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.

• Brand Name: TAPERFILL HIP STEM, LATERAL OFFSET, SIZE 9
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 16424134
• Report Number: 1644408-2023-00205
• Device Sequence Number: 20219752
• Product Code: LPH
• UDI-Device Identifier: 00888912078672
• UDI-Public: 00888912078672
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 03/24/2023

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 Model Number: 425-97-009
• Device Catalogue Number: 425-97-009
• Device Lot Number: 174R1401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2023
• Supplement Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 400-03-363 LOT: 868B1517.; 940-00-035 LOT: 148Z1130.; 940-02-52F LOT: 800Z1212.; 942-01-36F LOT: 622Z1081.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male