MAUDE Adverse Event Report: ENCORE MEDICAL L.P. LINEAR HIP STEM; LINEAR, LATERAL, REDUCED NECK, SZ 13, W/P2 COATING

Model Number	932-36-252
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the patient having a periprosthetic hip fracture.The surgeon removed the original stem and head and went to a revision hip system.He replaced the original 10 degree liner with a 20 degree liner.
Additional Manufacturer Narrative
Corrected data: see brand name, common device name, concomitant medical products.Manufacturer narrative: the reason for this revision surgery was due to periprosthetic fracture.The previous surgery and the surgery detailed in this investigation occurred 3.5 years apart.The healthcare professional indicated there was a significant adverse event to the patient.There was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the implant device history records (dhr), shows that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports associated with the product that may have contributed to the reported event.The device was 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 device showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to periprosthetic fracture.There were no findings during this investigation that indicate that the reported device was defective.No other 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 of the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: LINEAR HIP STEM
• Common Device Name: LINEAR, LATERAL, REDUCED NECK, SZ 13, W/P2 COATING
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 8709891
• Report Number: 1644408-2019-00558
• Device Sequence Number: 16719134
• Product Code: LPH
• UDI-Device Identifier: 00888912100076
• UDI-Public: (01)00888912100076
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K120241
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019

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: 12/28/2020
• Device Model Number: 932-36-252
• Device Catalogue Number: 425-99-013
• Device Lot Number: 578G1014
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 07/30/2019
• 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: 400-03-362 LOT 866B1101; 400-03-362, LOT 866B1101; 425-99-013, LOT 578G1014; 932-36-252 LOT 728F1137
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 62 YR