MAUDE Adverse Event Report: ENCORE MEDICAL L.P EXPRT HIP; EXPRT REVISION HIP, DISTAL STEM, 16X210

Model Number	495-16-210
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Event or Problem Description
Second revision surgery - patient had major subsidence on exprt stem, replaced stem with zimmer.Left shell and put a liner in.
Additional Manufacturer Narrative
The reason for this revision surgery was reported as subsidence on stem.The previous surgery and the surgery detailed in this event occurred 3 years and 9 months apart.The healthcare professional indicated there was a serious risk 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 hospital and not made available to djo surgical for examination.A review of the device history record (dhr) shows that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.At first, there was an ncmr-35132 associated with the main part #495-16-210 exprt revision hip, distal stem, 16x210 which documents that out of 26 parts lot, all parts were rejected due to product packaged requires new ifu inserted into packaging.Later the rejected parts were reworked and accepted after proper justification.Secondly, there was an ncmr-35658 associated with the same part which documents that out of 26 parts lot, all parts were rejected due to improper packaging.Later the rejected parts were reworked and accepted after proper justification.The device was verified to have gone through an acceptable sterilization process and was within its 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 needing a review.The root cause of this complaint was a revision surgery due to subsidence on stem.There were no findings during this evaluation that indicate the reported device was 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 also contribute to an event that are outside the control of djo surgical such as poor bone density, patient bone deterioration, inadequate soft tissue support, patient activities or trauma.There are no indications of a product or process issue affecting implant safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: EXPRT HIP
• Common Device Name: EXPRT REVISION HIP, DISTAL STEM, 16X210
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin,tx 78758-5445
• MDR Report Key: 11568852
• Report Number: 1644408-2021-00213
• Device Sequence Number: 11813654
• Product Code: KWZ
• UDI-Device Identifier: 00190446153993
• UDI-Public: (01)00190446153993
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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: 02/04/2023
• Device Model Number: 495-16-210
• Device Catalogue Number: 495-16-210
• Device Lot Number: 599U1001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 05/19/2021
• 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: Other; Required Intervention
• Patient Age: 72 YR