MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FMP HIP; FMP HEMISPHERICAL SHELLS W/SCREW HOLES, 56MM, W/P2 COATING

Model Number	430-98-056
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Left in patient.
Event or Problem Description
Original surgery - the threads came out on shell into the inserter.The offset inserter broke free and ripped the threads out of the dome, item was left in the patient.
Additional Manufacturer Narrative
The reason for this complaint was to report the threads came out on shell into the inserter.The offset inserter broke free and ripped threads out of the dome, item was left in patient.The in-vivo length of patient service for the implant was not a factor for this complaint as it was the primary surgery.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this surgery.There are no reported pre-existing patient health conditions.The healthcare professional indicated there was a 5 minute delay in surgery and another suitable device was available for use.The surgery was completed as intended.The item was left in the patient 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 threads of the acetabular shell were pulled from shell the insertion instrument.The scope of this investigation is limited without having the explanted parts available to djo surgical for evaluation.It is possible the threads of the shell and insertion instrument became crossed and the threads were levered out of the shell.No definitive conclusion can be made from the information available.Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: FMP HIP
• Common Device Name: FMP HEMISPHERICAL SHELLS W/SCREW HOLES, 56MM, W/P2 COATING
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6623017
• Report Number: 1644408-2017-00424
• Device Sequence Number: 602317
• Product Code: LPH
• UDI-Device Identifier: 00888912084048
• UDI-Public: (01)00888912084048
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K974093
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/08/2023
• Device Model Number: 430-98-056
• Device Catalogue Number: 430-98-056
• Device Lot Number: 591G1187
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/10/2017
• Supplement Date Received by Manufacturer: 08/14/2017
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 09/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR