MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FMP HIP; FMP HEMISPHERICAL SHELLS W/SCREW HOLES, 58MM, W/P2 COATING

Model Number	430-98-058
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - the shell had loosened.
Additional Manufacturer Narrative
The reason for this revision surgery was due to the shell had loosened.The previous surgery and the revision detailed in this investigation occurred over 2 years and 4 months apart.The healthcare professional indicated there was no significant adverse event to the patient.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 component used in the previous surgery, when released for use, met design and manufacturing requirements.There were no nonconforming material reports associated with the product that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of 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 loosening.There are many factors that may contribute to the event that are outside the control of djo surgical such as poor bone density, inadequate soft tissue support, patient's age, degenerative bone disease, patient bone deterioration, patient activities or trauma.No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any activities that may have contributed to the event and hence a definitive root cause cannot be determined.

• Brand Name: FMP HIP
• Common Device Name: FMP HEMISPHERICAL SHELLS W/SCREW HOLES, 58MM, W/P2 COATING
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin texas 78758; austin TX 78758 5445
• MDR Report Key: 8875736
• Report Number: 1644408-2019-00732
• Device Sequence Number: 16741638
• Product Code: LPH
• UDI-Device Identifier: 00888912084062
• UDI-Public: (01)00888912084062
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K974093
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2019

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: 02/08/2023
• Device Model Number: 430-98-058
• Device Catalogue Number: 430-98-058
• Device Lot Number: 592G1110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/11/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 10/04/2019
• 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: 010-55-030 LOT 007A1190; 931-36-756 LOT 888N1947
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR