MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FMP HIP; FMP HEMISPHERICAL SHELLS W/SCREW HOLES, 62MM, W/P2 COATING

Model Number	430-98-062
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the patient having dislocated; the cup was too vertical.
Additional Manufacturer Narrative
The reason for this revision surgery was due to dislocation.The previous surgery and the revision detailed in this investigation occurred over 1 year part.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 (b)(4) for examination.A review of the implant device history records (dhr) shows that the reported component used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the event.The device was within its expiration date 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 dislocation.There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the patient's dislocation.There are multiple factors that may contribute to the event that are outside the control of (b)(4) are patient activities, excessive range-of-motion, loose joint from inadequate soft tissue or trauma.The agent clearly mentioned that cup was too vertical in its position and it seems that event may occurred due to improper surgical technique or unbalanced joint.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.Inventory containment is not required as 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, 62MM, W/P2 COATING
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6603250
• Report Number: 1644408-2017-00411
• Device Sequence Number: 18972110
• Product Code: LPH
• UDI-Device Identifier: 00888912084086
• UDI-Public: (01)00888912084086
• 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: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2017

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: 12/31/2020
• Device Model Number: 430-98-062
• Device Catalogue Number: 430-98-062
• Device Lot Number: 594G1030
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/01/2017
• Supplement Date Received by Manufacturer: 06/16/2017
• Initial Report FDA Received Date: 05/31/2017
• Supplement Report FDA Received Date: 07/14/2017
• 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: 72 YR