MAUDE Adverse Event Report: ENCORE MEDICAL L.P. TAPERFILL HIP; TAPERFILL HIP STEM, LATERAL OFFSET, SIZE 17

Model Number	425-97-017
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - subsequently the patient dislocated his hip on two different occasions.Surgeon decided to do a revision to stabilize the hip.Intraoperatively, he found it necessary to remove all of the implants and go from a 17 lateral taperfill to a 19 lateral taperfill.He also elected to use a 58mm bipolar with 28mm +10.5mm femoral head instead of the 60mm unpolar/+3.5mm offset sleeve.The new construct proved much, more stable throughout range of motion.There were no issues during the original nor the revision surgery.
Additional Manufacturer Narrative
The reason for this revision surgery was reported as dislocation.The previous surgery and the surgery detailed in this event occurred 37 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.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 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, 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: TAPERFILL HIP
• Common Device Name: TAPERFILL HIP STEM, LATERAL OFFSET, SIZE 17
• 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: 15588999
• Report Number: 1644408-2022-01343
• Device Sequence Number: 2748987
• Product Code: LPH
• UDI-Device Identifier: 00888912078757
• UDI-Public: (01)00888912078757
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/12/2022

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: 425-97-017
• Device Catalogue Number: 425-97-017
• Device Lot Number: 182R1969
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2022
• Initial Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2021
• 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: 411-00-160 LOT 928B1041; 411-00-350 LOT 931B2006
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 85 KG