MAUDE Adverse Event Report: ENCORE MEDICAL L.P. OMEGA HIP; NECK, FEMORAL, MODULAR, 32MM 8 CERASIVE TAPER

Model Number	497-28-035
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/24/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the neck dissociating from the stem.The surgeon cemented the neck into place and replaced the head.
Additional Manufacturer Narrative
The reason for this revision surgery was due to the neck having dissociated from stem.The previous surgery and the revision detailed in this investigation occurred 3.8 years apart.There is no information in this complaint about any patient injuries, 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 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 met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) 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 use during 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 the neck having dissociated from the stem.There were no findings during this investigation that indicate that the reported device was defective.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this revision surgery was due to the neck having dissociated from stem.The previous surgery and the revision detailed in this investigation occurred 3.8 years apart.There is no information in this complaint about any patient injuries, 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 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 met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) 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 use during 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 the neck having dissociated from the stem.There were no findings during this investigation that indicate that the reported device was defective.Due to the technique/procedure of removing a head from the construct, the stem and shell have been added to the affected items.It is likely that some components may have been replaced with competitor's product but could not be confirmed.Per the report, the neck was not replaced, but it was the main contributor to the event.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: OMEGA HIP
• Common Device Name: NECK, FEMORAL, MODULAR, 32MM 8 CERASIVE TAPER
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7386465
• Report Number: 1644408-2018-00286
• Device Sequence Number: 196150
• Product Code: LPH
• UDI-Device Identifier: 00888912087278
• UDI-Public: (01)00888912087278
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K000817
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2018

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: 09/28/2019
• Device Model Number: 497-28-035
• Device Catalogue Number: 410-32-108
• Device Lot Number: 896B1051
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/28/2018
• Supplement Date Received by Manufacturer: 04/24/2018; 07/10/2018
• Initial Report FDA Received Date: 03/30/2018
• Supplement Report FDA Received Date: 04/24/2018; 07/10/2018
• 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: 412-02-049 , LOT 996B1042; 497-28-035, LOT 631C1112
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 71 YR