MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FMP HIP; LINER, ACETABULAR, FMP CONSTRAINED 28XMP7

Model Number	436-28-007
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was due to patient having pulled out of the constrained liner.The previous surgery and the revision detailed in this investigation occurred over 1 year and 1 month apart.The healthcare professional indicated there was a 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 components used in the previous surgery met design and manufacturing requirements.There was a nonconformance in the part #436-28-007, liner, acetabular, fmp constrained 28xmp7 which documents nonconformance that out of 10 parts lot, 1 part was rejected and scrapped due to poor legibility of the engraving.All other item in the lot were met with the design, fit and function requirements.The device was within its respective 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 patient pulled out of the constrained liner.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 event.There are many factors that may contribute to the event that are outside the control of djo surgical such as poor bone density, patient bone deterioration, inadequate soft tissue support, excessive range of motion, patient activities or trauma.No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any patient activities that may have contributed to the event and hence a definitive root cause cannot be determined.There are no indications of a product or process issue affecting implant safety or effectiveness.The revision surgery was completed successfully.
Event or Problem Description
Revision surgery - due to the patient having pulled out of the previous constrained liner.The surgeon removed the previous components and replaced them.He will be going back in, in the future to remove the cup.The cup is in a very vertical position.

• Brand Name: FMP HIP
• Common Device Name: LINER, ACETABULAR, FMP CONSTRAINED 28XMP7
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 8951279
• Report Number: 1644408-2019-00806
• Device Sequence Number: 2470933
• Product Code: KWZ
• UDI-Device Identifier: 00888912085700
• UDI-Public: (01)00888912085700
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K023794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2019

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: 06/17/2021
• Device Model Number: 436-28-007
• Device Catalogue Number: 436-28-007
• Device Lot Number: 499C1008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/30/2019
• 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: 400-04-280 LOT 881B1017; 400-05-000 LOT 886B1114; 436-28-000 LOT 496C1076
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 84 YR