MAUDE Adverse Event Report: ENCORE MEDICAL L.P. LIMA HIP; ACE CAGE, STD. 58MM

Model Number 428-01-060

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Code Available (3191)

Event Date 09/19/2018

Event Type  Injury  

Event Description

Second revision surgery - due to the acetabular cage being loose.Everything was removed except the distal stem.The surgeon implanted a new proximal body and 22 millimeter head.Another vendor was used for new acetabular components.The agent confirmed that the liner was removed as well.

Manufacturer Narrative

Manufacturer narrative: the reason for this revision surgery was due to a loose acetabular cage.The previous surgery and the surgery detailed in this investigation occurred 2.8 years apart.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.There are no reported pre-existing patient health conditions.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 device was disposed of at the hospital and not made available to djo surgical for examination.A review of the implant device history records (dhr), shows that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of use during the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to a loose acetabular cage.There were no findings during this investigation that indicate that the reported device was defective.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: LIMA HIP
• Type of Device: ACE CAGE, STD. 58MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7939635
• MDR Text Key: 123039494
• Report Number: 1644408-2018-00909
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 00888912023696
• UDI-Public: (01)00888912023696
• Combination Product (y/n): N
• PMA/PMN Number: K002941
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2016
• Device Model Number: 428-01-060
• Device Catalogue Number: 494-00-058
• Device Lot Number: 1007431
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/19/2018
• Initial Date FDA Received: 10/05/2018
• Supplement Dates Manufacturer Received: 11/27/2018
• Supplement Dates FDA Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 010-55-025, LOT 006A1141; 010-55-025, LOT 006A1189; 010-55-025, LOT 006A1189; 010-55-025, LOT 728F1141; 010-55-030, LOT 007A1104; 010-55-030, LOT 007A1104; 010-55-030, LOT 007A1117; 010-55-030, LOT 007A1117; 010-55-035, LOT 009A1063; 010-55-035, LOT 009A1063; 411-00-000, LOT 902B1913; 411-00-000, LOT 902B1913; 428-01-060, LOT 1503318; 430-98-052, LOT 587G1141; 430-98-052, LOT 587G1141; 494-00-058, LOT 1007431; 497-36-000, LOT 638C1159; 497-36-000, LOT 638C1159; 932-36-252, LOT 728F1141; 932-36-252, LOT 728F1141
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR