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

Model Number	940-02-54G
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2022
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
Primary surgery - cup was inserted with standard technique and instrumentation.Liner would not seat properly.A total of 3 liners were attempted to implant.A new cup was opened and liner seated properly.All three of the liners listed were removed along with the cup.
Additional Manufacturer Narrative
The reason for this primary surgery was reported as the liners were unable to seat properly with the cup.The healthcare professional indicated this event occurred during surgery near the patient.The surgeon reported significant adverse event and there was a 45 minute delay in surgery.The device was inspected prior to use and found to be acceptable.The agent was present during surgery and was able to provide another suitable device.Surgery was completed as intended.The devices were returned to the manufacturer and made available at djo surgical for evaluation.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 were no non-conforming material reports (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 reported lot number does not have any other similar complaints.The root cause of this complaint is that the liners were unable to seat properly with the cup.It is likely that there was foreign debris such as tissue or bone that was interfering with the interface of the components.The inspection sheet indicates the devices were conforming and were within specifications.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.This is an event is not associated with product failure, malfunction, or issue.There are no indications of a product or process issue affecting implant safety or effectiveness.Rma examination: the reported devices were returned to surgical for evaluation.The liners indicate that there was slight offset during installation.The interior of the cup indicates some surface level scratches, however, this would not interfere with the fit of the components.

• 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
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 15663108
• Report Number: 1644408-2022-01386
• Device Sequence Number: 6499161
• 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: 2022
• 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): 01/09/2023

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: 801Z1185
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2022
• Supplement Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 941-01-36G LOT 599Z1008.; 941-01-36G LOT 599Z1101.; 941-01-36G LOT 599Z1117.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR
• Patient Sex: Male