MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION HIP; STEM, HIP, FH, 450 SERIES, SIZE8MM

Model Number	931-28-748
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Second revision surgery - patient had previous hip revision surgery and was still experiencing pain.Surgeon elected to remove the stem that was implanted (not djo) and revise it to another system (not djo).He requested a new liner with a larger head option.So, we revised the liner from 28mm diameter to 32mm option.
Additional Manufacturer Narrative
Corrected data: see d.1., d.2., d.4., d.11 & g.5.Manufacturer narrative: the reason for this revision surgery was reported as pain.The previous revision surgery and the revision surgery detailed in this event occurred 2.7 years apart.The liner in vivo time is 3.9 years, from the primary surgery.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 no non-conforming material report (ncmr) associated with the products that may have contributed to the reported event.The devices were verified to have gone through an acceptable sterilization process and were within its expiration date 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 pain.There were no findings during this evaluation that indicate the reported devices were defective.No 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.There are multiple factors that may contribute to an event that are outside the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: FOUNDATION HIP
• Common Device Name: STEM, HIP, FH, 450 SERIES, SIZE8MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445,
• MDR Report Key: 9511010
• Report Number: 1644408-2019-01263
• Device Sequence Number: 19387128
• Product Code: JDI
• UDI-Device Identifier: 00888912099431
• UDI-Public: (01)00888912099431
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K961890
• 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): 03/05/2020

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: 05/28/2021
• Device Model Number: 931-28-748
• Device Catalogue Number: 450-01-080
• Device Lot Number: 538C1019
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 03/05/2020
• 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: 497-28-105 LOT 632C1043.; 932-28-248 LOT 722F1000.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR