MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION HIP; STEM, HIP FRACTUREURE 9MM COLLARLESS 440 SERIES

Model Number	440-00-090
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was reported as fracture from a fall.The previous surgery and the surgery detailed in this event occurred 1 month and 3 weeks apart.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 devices were disposed of at hospital and not made available to djo surgical for examination.A review of the device history records (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There was a ncmr#25279 associated with the main part #440-00-090, stem, hip fracture 9mm collarless 440 series, which documents that out of 1 part lot, 1 part was rejected due to uneven polish surface.After suitable rework the part was accepted.The devices were verified to have gone through an acceptable sterilization process and were within its expiration dates at the time of the previous surgery.Customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to fracture from a fall.There were no findings during this evaluation that indicate the reported devices were defective.No other information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the event.The agent has clearly mentioned that "patient fell at nursing home resulting in a peri prosthetic fracture.All implants removed and revised with expert".It seems that the event might have possibly occurred due to lack of post-operative care, patient noncompliance with medical instructions, patient activities or trauma.There are no indications of a product or process issue affecting implant safety or effectiveness.
Event or Problem Description
Revision surgery - patient fell at nursing home resulting in a peri prosthetic fracture.All implants were removed and revised with expert.

• Brand Name: FOUNDATION HIP
• Common Device Name: STEM, HIP FRACTUREURE 9MM COLLARLESS 440 SERIES
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 9249623
• Report Number: 1644408-2019-01044
• Device Sequence Number: 13996284
• Product Code: JDI
• UDI-Device Identifier: 00888912085922
• UDI-Public: (01)00888912085922
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K973809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 10/29/2019

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: 03/31/2021
• Device Model Number: 440-00-090
• Device Catalogue Number: 440-00-090
• Device Lot Number: 519C1013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 10/29/2019
• 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: 400-01-221 LOT 777B1188; 412-02-043 LOT 987B1067
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR