MAUDE Adverse Event Report: ENCORE MEDICAL L.P. KERAMOS HIP; LINER, CERAMIC ,AL-AL 32X52/54MM

Model Number	400-01-297
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/17/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the linear breaking.
Additional Manufacturer Narrative
The reason for this revision surgery was the patient's ceramic hip liner broke.The in-vivo length of patient service for the implant was 11.8 years.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 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 device history records (dhrs) revealed no discrepancies or issues with the manufacturing of this part.All critical dimensions, design criteria and specifications in effect at the time the part was manufactured were met.The product complaint report history was reviewed and no trends or on-going issues were deemed as present or in need of review.This event is deemed as non-product related.The root cause for this event was the patient's ceramic hip liner broke.The complaint states the patient hip liner broke.No information was provided that further explained the nature of the event related to a possible cause and reasons.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.
Additional Manufacturer Narrative
The initial mdr reported 400-01-297, lot number 891511 as the suspect medical device.Follow-up #1 corrected the suspect medical device to 498-01-054, lot number 224442 and corrected the concomitant part to 400-01-297,lot 891511.Quality assurance has changed the suspect medical device to 498-32-052, lot number 221092 with the same concomitant part of 400-01-297, lot number 891511.Follow-up #2 is making this correction and the following manufacturer narrative is for the corrected suspect medical device.Manufacturer narrative: the reason for this revision surgery was the patient's ceramic hip liner broke.The in-vivo length of patient service for the implant was 11.8 years.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 device history records (dhrs) revealed no discrepancies or issues with the manufacturing of this part.All critical dimensions, design criteria and specifications in effect at the time the part was manufactured were met.The product complaint report history was reviewed and no trends or on-going issues were deemed as present or in need of review.This event is deemed as non-product related.The root cause for this event was the patient's ceramic hip liner broke.No information was provided that further explained the nature of the event related to a possible cause and reasons.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: KERAMOS HIP
• Common Device Name: LINER, CERAMIC ,AL-AL 32X52/54MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6570638
• Report Number: 1644408-2017-00367
• Device Sequence Number: 2059298
• Product Code: MRA
• UDI-Device Identifier: 00888912075749
• UDI-Public: (01)00888912075749
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: D138902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• 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): 08/28/2017

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: 07/31/2009
• Device Model Number: 400-01-297
• Device Catalogue Number: 498-32-052
• Device Lot Number: 2231092
• 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: Not provided; 08/28/2017
• Initial Report FDA Received Date: 05/16/2017
• Supplement Report FDA Received Date: 06/23/2017; 08/28/2017
• 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: 60 YR