MAUDE Adverse Event Report: ENCORE MEDICAL L.P. TAPERFILL HIP; TAPERFILL HIP STEM, LATERAL OFFSET, SIZE 16

Catalog Number	425-97-016
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Joint Dislocation (2374)
Date of Event	11/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to previous report number 1644408-2022-01295, 425-96-008, s800 - revision surgery, s803 - dislocation, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.
Event or Problem Description
Revision surgery - upon weight bearing, the patient sustained a peri prosthetic fracture and dislocation of the hip.Surgeon revised the hip and removed the size 16 lateral taperfill stem, 40 head and neutral offset sleeve.Surgeon placed a cable to fix the fracture and implanted a size17 lateral taperfill stem, 40 head and +10.5mm offset sleeve.

• Brand Name: TAPERFILL HIP
• Common Device Name: TAPERFILL HIP STEM, LATERAL OFFSET, SIZE 16
• 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: 18229381
• Report Number: 1644408-2023-01731
• Device Sequence Number: 6202564
• Product Code: LPH
• UDI-Device Identifier: 00888912078740
• UDI-Public: (01)00888912078740
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/29/2023

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 Catalogue Number: 425-97-016
• Device Lot Number: 181R2050A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2023
• 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: 411-00-000 LOT 902B2096.; 497-40-000 LOT 641C1131A.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male