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

Model Number	430-98-056
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reported incident - acetabular bone screw appeared to advance beyond the cluster hole of the fmp shell.The screw was drilled using the fmp drill guide, short 3.3 millimeter drill bit, and fmp drill bit shaft.An fmp department gauge was used to measure the screw length and the 40 millimeter screw was inserted by hand by the surgeon.The real liner was then impacted in place in usual fashion.Upon review of the intra operative x-ray for the femoral broach, it was noticed that the acetabular bone screw appeared to have advanced farther than the bottom of the shell.
Additional Manufacturer Narrative
Manufacturer narrative: this mdr will be voided.The screw remained in the patient with the original implant.Nothing was removed and surgery was completed as intended.

• Brand Name: FOUNDATION 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: 7419298
• Report Number: 1644408-2018-00332
• Device Sequence Number: 69674
• Product Code: LPH
• UDI-Device Identifier: 00888912084048
• UDI-Public: (01)00888912084048
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K974093
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2018

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 Model Number: 430-98-056
• Device Catalogue Number: 430-98-056
• Device Lot Number: 591G1228
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/28/2018
• Supplement Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 05/04/2018
• 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: 010-55-040, LOT 010A1138
• Patient Age: 89 YR