MAUDE Adverse Event Report: ENCORE MEDICAL L.P. LINEAR HIP; STEM, HIP, FEMORAL, LINEAR SIZE7 STD. REDUCED NECK

Model Number	425-01-007
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/26/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - the stem was loose due to a fracture.
Additional Manufacturer Narrative
Corrected data: lot number for concomitant part number 497-34-000 was corrected from lot 36c1000 to lot 636c1000.Manufacturer narrative: the reason for this revision surgery was the stem was loose due to a fracture.The in-vivo length of patient service for the implant was 6.9 years.There is no information in this complaint about any patient activities, or accidents that may have contributed to the need for this revision surgery.There are no reported pre-existing patient health conditions.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 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 components used in the previous surgery met design and manufacturing requirements.There were 2 non-conforming material reports (ncmr) associated with the part 425-01-007, hip, stem, linear, standard, reduced neck, size 7.Both ncmr (b)(4) states the identical nonconformance (b)(4) were rejected due to dark spots on porous coating and were reworked with suitable operations and accepted.All items in the lot met the fit, design and functional requirements.The device and its applicable concomitant devices were within their respective expiration dates at the time of use during the previous surgery.Customer complaint history of the reported device (s) showed no present trends or on-going issues that are in need of review.This event is deemed to be non-product related.The root cause of this complaint was a revision surgery due to the loosening.There are many factors that may contribute to the event that are outside the control of djo surgical are loose joints from inadequate soft tissue support, degenerative bone, excessive range of motion.Agent has mentioned that the stem was loose due to a fracture, so the event may possibly have occurred due to patient activities or trauma.No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any activities that may have contributed to the event and hence a definitive root cause cannot be determined.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: LINEAR HIP
• Common Device Name: STEM, HIP, FEMORAL, LINEAR SIZE7 STD. REDUCED NECK
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6974703
• Report Number: 1644408-2017-00907
• Device Sequence Number: 16511460
• Product Code: LPH
• UDI-Device Identifier: 00888912077835
• UDI-Public: (01)00888912077835
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K991325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2017

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: 07/28/2016
• Device Model Number: 425-01-007
• Device Catalogue Number: 425-01-007
• Device Lot Number: 057C1007
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/26/2017
• Supplement Date Received by Manufacturer: 11/06/2017
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 11/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR