MAUDE Adverse Event Report: ENOVRE MEDICAL L.P. DJO SURGICAL; EMPOWR ACET SYSTEM, CUP, HEMISPHERICAL, CLUSTER HOLE, 50MM

Catalog Number	940-02-50E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number 1644408-2022-00998; 940-01-56h, s810 - device loosening, revision surgery; surgical - quality complaints.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.
Event or Problem Description
Revision surgery - due to loosening.

• Brand Name: DJO SURGICAL
• Common Device Name: EMPOWR ACET SYSTEM, CUP, HEMISPHERICAL, CLUSTER HOLE, 50MM
• Manufacturer (Section D): ENOVRE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer (Section G): ENOVRE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: stacey bonnell ; 9800 metric blvd; austin, TX 78758 ; 5128346313
• MDR Report Key: 20873937
• Report Number: 1644408-2024-01875
• Device Sequence Number: 8904954
• Product Code: LPH
• UDI-Device Identifier: 00190446311553
• UDI-Public: 00190446311553
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K190057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/07/2024

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 Catalogue Number: 940-02-50E
• Device Lot Number: 799Z1187
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 12/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2022
• 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: 400-03-281 LOT: 857B1248.; 951-01-40E LOT: 2216A1020.; 952-28-40E LOT: 2224A1051.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Female