MAUDE Adverse Event Report: ENCORE MEDICAL L.P LIMA HIP; REV DISTAL STM, 20X140MM

Model Number 428-20-140

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/22/2019

Event Type  Injury  

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

Event Description

Revision surgery - due to the lima hip stem allegedly breaking.

Event Description

Second revision surgery - due to the lima hip stem allegedly breaking.

Manufacturer Narrative

The reason for this revision surgery was reported as broken stem.The previous surgery and the surgery detailed in this event occurred 6.2 years apart.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 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 root cause of this complaint was a revision surgery due to broken stem.There were no findings during this evaluation that indicate the reported devices were defective.No other 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.There are multiple factors that may 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 as soon as it becomes available.

• Brand Name: LIMA HIP
• Type of Device: REV DISTAL STM, 20X140MM
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 11744764
• MDR Text Key: 247938568
• Report Number: 1644408-2021-00342
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00888912023733
• UDI-Public: (01)00888912023733
• Combination Product (y/n): N
• PMA/PMN Number: K092331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: 428-20-140
• Device Catalogue Number: 428-20-140
• Device Lot Number: 1106638
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 010-55-020 LOT 005A1042; 010-55-030 LOT 007A1039; 411-00-000 LOT 902B1082; 428-00-080 LOT 1100546; 430-98-054 LOT 590G1008; 497-36-000 LOT 638C1061; 932-36-254 LOT A1000002; 010-55-020 LOT 005A1042; 010-55-030 LOT 007A1039; 411-00-000 LOT 902B1082; 428-00-080 LOT 1100546; 430-98-054 LOT 590G1008; 497-36-000 LOT 638C1061; 932-36-254 LOT A1000002
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR