MAUDE Adverse Event Report: ENCORE MEDICAL L.P. LIMA HIP; REV BODY, LAT. 100MM

Model Number	428-01-100
Health Effect - Clinical Codes	Joint Dislocation (2374); No Code Available (3191)
Date of Event	07/18/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the patient presenting at the emergency room for a dislocated hip.The surgeon decided to revise the patients implants as the hip stem had subsided and the patient's hip was now unstable.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this revision surgery was the patient presented at emergency room for a dislocated hip.The surgeon decided to revise the patient's implants as the hip stem had subsided and patient hip was now unstable.The in-vivo length of patient service for the implant was 1 year and 7 months.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 will be held in the hospital for 2-4 weeks and has not been 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 event.The device 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.This event is deemed to be non-product related.The root cause of this complaint was a revision surgery due to the dislocation.There are multiple factors that may contribute to the event that are outside the control of djo surgical are loose joint from inadequate soft tissue, excessive range of motion, patient bone deterioration, 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: LIMA HIP
• Common Device Name: REV BODY, LAT. 100MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6801981
• Report Number: 1644408-2017-00670
• Device Sequence Number: 16529080
• Product Code: KWA
• UDI-Device Identifier: 00888912081399
• UDI-Public: (01)00888912081399
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K092331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2017

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: 12/31/2018
• Device Model Number: 428-01-100
• Device Catalogue Number: 428-01-100
• Device Lot Number: 1312020
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/18/2017
• Supplement Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 08/17/2017
• Supplement Report FDA Received Date: 10/07/2017
• 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: 428-18-140,LOT 1303671
• Outcome Attributed to Adverse Event: Required Intervention