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

Model Number	940-02-54G
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Complaint - due to shell not seating properly.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this revision surgery was reported as shell not seating properly.The previous surgery and the surgery detailed in this event occurred was unknown.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 returned and examined, it showed residual bone which prevented dimensional inspection.Examination of the returned devices : item : 940-02-54g - it was reported, "i looked at the returned parts on friday and the 940-02-54g cup still has the dome peg remnant present.The dome peg should be machined away flush with the coating so a step was missed.The rep said the clustercup was being returned because "the cluster cup was from a case where one of the solid cups wasn't getting any bite.He switched to a cluster but ended up having to ream up to a bigger size." they did not notice the dome pegremnant so we didn't know about this until we got the parts back friday.Item : 940-01-54g - they were too tight even after reaming line-to-line.These were solid back cups and when he (the surgeon) switched to a cluster hole cup they seated properly.He mentioned these patients had been older females withrelatively poor bone quality.He is asking us to reinspect the cups to check coating thickness.A review of the device history records (dhr) shows that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.All items in the lot were reported to meet design, fit, and functional requirements.The devices were verified to have gone through an acceptable sterilization process and were within expiration date at the time of the previous surgery.Customer complaint history of the reported devices showed no other occurrences of the reported issues.Additional reportind on this item will be provided as a supplemental report to this document as soon as it becomes available.
Additional Manufacturer Narrative
The reason for this complaint was reported as shell not seating properly.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 returned and examined, it showed residual bone which prevented dimensional inspection.Examination of the returned devices: item: 940-02-54g: it was reported, "i looked at the returned parts on friday and the 940-02-54g cup still has the dome peg remnant present.The dome peg should be machined away flush with the coating so a step was missed.The rep said the clustercup was being returned because "the cluster cup was from a case where one of the solid cups wasn't getting any bite.He switched to a cluster but ended up having to ream up to a bigger size." they did not notice the dome pegremnant so we didn't know about this until we got the parts back.Item: 940-01-54g: they were too tight even after reaming line-to-line.These were solid back cups and when the surgeon switched to a cluster hole cup they seated properly.He mentioned these patients had been older females with relatively poor bone quality.He is asking us to reinspect the cups to check coating thickness.A review of the device history records (dhr) shows that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.All items in the lot were reported to meet design, fit, and functional requirements.The devices were verified to have gone through an acceptable sterilization process and were within expiration date at the time of the previous surgery.Customer complaint history of the reported devices showed no other occurrences of the reported issues.Additional reportind on this item will be provided as a supplemental report to this document as soon as it becomes available.

• Brand Name: DJO ACETABULAR SYSTEM
• Common Device Name: EMPOWR ACET SYSTEM, CUP, HEMISPHERICAL, CLUSTER HOLE, 54MM
• Manufacturer (Section D): ENCORE MEDICAL L. P.; 9800 metric blvd; austin, tx
• MDR Report Key: 10485432
• Report Number: 1644408-2020-00836
• Device Sequence Number: 14417989
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/08/2021

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: 05/06/2026
• Device Model Number: 940-02-54G
• Device Catalogue Number: 940-02-54G
• Device Lot Number: 801Z1036
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 12/15/2020; 12/15/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 01/15/2021; 02/08/2021
• 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: 940-01-54G, LOT 786Z1003
• Outcome Attributed to Adverse Event: Required Intervention