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	Pain (1994)
Date of Event	09/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the patient complaining of pain in the right hip joint.The surgeon removed the cup and the liner and replaced with another company's cup.He also replaced the head.
Additional Manufacturer Narrative
The reason for this revision surgery was due to the pain.The previous surgery and the revision detailed in this investigation occurred 2.4 years apart.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.Initial or prolonged hospitalization was required.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 was a non-conforming material report (ncmr) # 26858 associated with the par t# 430-98-056, fmp hemispherical shells with screw holes, 56 millimeter, with porous 2 (p2) coating, which documents a nonconformance that out of 20 quantity lot 1 item was rejected, due to discoloration spotted in the porous coating portion of the part.It was reworked with suitable operations and accepted.All other items in the lot met design, fit and function requirements and were accepted.The device was within its expiration dates at the time of use during the previous surgery.Customer complaint history of the reported device 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 the pain.There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the event.There are multiple factors that may contribute to the event that are outside the control of djo surgical such as: degenerative bone disease, patient bone deterioration, soft tissue impingement, patient activities or trauma.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• 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: 7939674
• Report Number: 1644408-2018-00906
• Device Sequence Number: 10954948
• Product Code: LPH
• UDI-Device Identifier: 00888912084048
• UDI-Public: (01)00888912084048
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K974093
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 430-98-056
• Device Catalogue Number: 430-98-056
• Device Lot Number: 591G1113
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/19/2018
• Supplement Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 10/09/2018
• 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: 400-03-361, LOT 864B1152; 931-36-756, LOT 888N1916
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 47 YR