MAUDE Adverse Event Report: ENCORE MEDICAL L.P DISC ULNA; DISC ULNA 3X155MM LT W BRNG C

Catalog Number 114818

Device Problems Loose or Intermittent Connection (1371); Material Protrusion/Extrusion (2979); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 02/25/2021

Event Type  Injury  

Manufacturer Narrative

This evaluation is limited in scope as the item(s) associated with this investigation was not returned to djo surgical - (b)(6) for examination.The surgery was completed as intended and without incident.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.There was no other information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.There were no findings during this evaluation that indicate that the reported device(s) was defective.The surgeon performed this procedure to remedy the patient's condition.No further action is deemed necessary.The root cause of this complaint was a revision surgery due to the component became loose and protruded out the bone, causing pain and instability.Rep stated the patient has a pre-existing condition of rheumatoid arthritis.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 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.The revision surgery was completed successfully.A review of the implant device history records shows that the reported component(s) used in the previous surgery, when released for use, met design and manufacturing requirements.There were no nonconforming material reports associated with the product(s) that may have contributed to the reported event.The device(s) was within its expiration date at the time of the previous surgery.Customer complaint history of the reported device(s) showed no present trends or on-going issues that are needing a review.

Event Description

Revision surgery - patient has rheumatoid arthritis.Ulna component became loose and protruded out the bone.Causing pain and instability.The previous surgery and the surgery detailed in this event occurred 3.2 years apart.

• Brand Name: DISC ULNA
• Type of Device: DISC ULNA 3X155MM LT W BRNG C
• 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: kiersten soderman ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 12619988
• MDR Text Key: 276094417
• Report Number: 1644408-2021-01091
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00888912225182
• UDI-Public: (01)00888912225182
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/06/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 12/22/2020
• Device Catalogue Number: 114818
• Device Lot Number: 153450
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 114700 , LOT 274050
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR