MAUDE Adverse Event Report: ENCORE MEDICAL L.P EMPOWR HIP; EMPOWR ACET SYSTEM, CUP, HEMISPHERICAL, CLUSTER HOLE, 54MM

Model Number	940-02-54G
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Second revision surgery - the patient has instability in the hip.The cup needed to be repositioned.The hip kept dislocating.
Additional Manufacturer Narrative
The reason for this revision surgery was reported as an instability.The previous surgery and the surgery detailed in this event occurred 8 days apart.The actual in-vivo time for the main part is 11 days 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 an ncmr-(b)(4) associated with the main part #940-02-54g empowr acet system, cup, hemispherical, cluster hole, 54mm which documents that out of 24 parts lot, 1 part was rejected due to roundness dimension out of tolerance.Later the rejected part was accepted after proper justification.All other items in the lot were met with fit, form and function requirements.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 instability, cup needed to be repositioned and the hip kept dislocating.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.Due to short time between previous and revision surgery, it is possible that the event may have occurred due to lack of post-operative care, patient activities or trauma, patient noncompliance with medical instructions or incorrect implant selection.There are multiple factors that may also 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.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: EMPOWR HIP
• Common Device Name: EMPOWR ACET SYSTEM, CUP, HEMISPHERICAL, CLUSTER HOLE, 54MM
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 11732021
• Report Number: 1644408-2021-00322
• Device Sequence Number: 14350319
• Product Code: LPH
• UDI-Device Identifier: 00190446311577
• UDI-Public: (01)00190446311577
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 05/31/2021

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 Model Number: 940-02-54G
• Device Catalogue Number: 940-02-54G
• Device Lot Number: 801Z1072
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 06/02/2021
• 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: 400-03-404 LOT 874B1116; 940-00-025 LOT 146Z1045; 940-00-040 LOT 149Z1026; 941-01-40G LOT 604Z1030; 400-03-404 LOT 874B1116; 940-00-025 LOT 146Z1045; 940-00-040 LOT 149Z1026; 941-01-40G LOT 604Z1030
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR