MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. LIMA HIP; REV DISTAL STM, 18X200MM

Model Number	428-18-200
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/01/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - it was reported the patient was revised.The original components were explanted and an antibiotic spacer was implanted.
Additional Manufacturer Narrative
The reason for this revision surgery was to replace the patient's existing components with an antibiotic spacer.The in-vivo length of patient service for the implant was 8 days.This complaint was filed per request from vista legal department.No information submitted with the complaint that would indicate a material, design, or manufacturing issue(s) with the explanted part(s).The complaint reported no surgical delays during the revision surgery.This complaint evaluation is limited in scope since the part (s) associated with this investigation was not returned to djo surgical for evaluation.The surgery was completed as intended and without incident.Review of the device history record (dhr) for the explanted part (s) revealed no discrepancies or issues during the manufacture of this part (s).The dhr evidences that all critical dimensions, design criteria and specifications in effect at the time the part was manufactured were met.The complaint investigation history was reviewed and no trends or on-going issues were deemed as present or in need of review.No issues or anomalies were observed with the concomitant part(s).This event is deemed as non-product related.The root cause for this event was to replace the patient's existing components with an antibiotic spacer.The requirement for the antibiotic spacer was undefined and is unknown at this time.One of the primary reasons for use of an antibiotic spacer is to resolve a patient infection but no information was submitted with the complaint regarding pre-existing conditions that may have contributed to the infection or inhibited the patient's immune system.The scope of this investigation is limited without having the explanted parts available to djo surgical for evaluation.Other conditions relating to this event could not be determined with confidence.Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: LIMA HIP
• Common Device Name: REV DISTAL STM, 18X200MM
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• MDR Report Key: 6562280
• Report Number: 1644408-2017-00344
• Device Sequence Number: 905527
• Product Code: LWJ
• UDI-Device Identifier: 00888912081504
• UDI-Public: (01)00888912081504
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K092331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2017

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: 07/31/2017
• Device Model Number: 428-18-200
• Device Catalogue Number: 428-18-200
• Device Lot Number: 1106331
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/17/2017
• Supplement Date Received by Manufacturer: 06/15/2017
• Initial Report FDA Received Date: 05/11/2017
• Supplement Report FDA Received Date: 07/14/2017
• 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: 428-00-090,LOT 1007341; 497-28-350,LOT 834C1013
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR