MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC ULNA E+ BEARING KIT

Model Number 540-01-001

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 05/04/2020

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery was reported due to loosening.The actual length of in-vivo for the items listed are unknown as the original surgery date was not provided or could be established.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 kept at hospital and not made available to djo surgical for examination.This investigation is limited in scope as only partial information was provided to djo surgical - austin for review.The revised items were not returned for examination and the item and or lot numbers were not provided.To adequately investigate this event, the part and or lot numbers are necessary.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 loosening.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.This complaint will be closed pending receipt of additional information.

Event Description

Revision surgery - due to loosening.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC ULNA E+ BEARING KIT
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx
• Manufacturer Contact: teffany hutto ; 9800 metric blvd; austin, tx
• MDR Report Key: 10108757
• MDR Text Key: 194309234
• Report Number: 1644408-2020-00415
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00190446254553
• UDI-Public: (01)00190446254553
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051975
• 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: 06/01/2020

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 Model Number: 540-01-001
• Device Catalogue Number: 540-01-001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/04/2020
• Initial Date FDA Received: 06/02/2020
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR