MAUDE Adverse Event Report: ENCORE MEDICAL L.P. TAPERFILL HIP; TAPERFILL HIP STEM, STANDARD, SIZE 12

Catalog Number	425-96-012
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/17/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - the patient had a procedure on (b)(6) 2017, on day 1 post operation, the patient's hip dislocated.After closer inspection of film, it was determined that combined anteversion was in excess of safe bone.The cup, liner and stem were extracted and replaced in order to solve the issue.
Additional Manufacturer Narrative
The reason for this revision surgery was the result of a patient hip dislocation and to remedy anteversion of the patient's hip joint.It was reported that after closer inspection of film, it was determined that combined anteversion was in excess of safe bone.The previous surgery and the revision detailed in this investigation occurred 1 day apart.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 no non-conforming material reports ncmrs associated with the product that may have contributed to a dislocation.The device was within it's respective expiration date 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.The root cause of this complaint was a revision surgery due to dislocation and patient hip anteversion.The anteversion may have been a contributing factor in the dislocation of the hip.No additional 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 dislocation 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.The revision surgery was completed successfully.
Additional Manufacturer Narrative
During quality review it was discovered 2 additional concomitant medical products needed to be reported.

• Brand Name: TAPERFILL HIP
• Common Device Name: TAPERFILL HIP STEM, STANDARD, SIZE 12
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6314556
• Report Number: 1644408-2017-00062
• Device Sequence Number: 919629
• Product Code: LPH
• UDI-Device Identifier: 00888912078573
• UDI-Public: (01)00888912078573
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K130099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2017

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: 05/26/2022
• Device Catalogue Number: 425-96-012
• Device Lot Number: 191R1923
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/17/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/09/2017
• Supplement Report FDA Received Date: 04/18/2017; 06/06/2017
• 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: 400-03-442, LOT 877B1068
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR