MAUDE Adverse Event Report: ENCORE MEDICAL L.P DISC HUM 4X100MM LT FLANGED C; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Catalog Number 540-34-100

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Joint Laxity (4526)

Event Date 09/19/2023

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 loosening and infection.

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2019-00498; 114800, s801 - device cracked/broke, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

Manufacturer Narrative

The reason for this revision surgery, the agent reported "(implant breakage previous case was over 20 years ago)".The actual length of in-vivo for the items listed is unknown as the original surgery date was not provided or could be established.This investigation is limited in scope as only partial information was provided to djo surgical - austin for review.The revised items was not returned for examination and the item and or lot numbers was not provided.To adequately investigate this event, the part and lot numbers are necessary.If this information is submitted at a future date, this investigation will be re-evaluated.Customer complaint history of the reported items showed no present trends or on-going issues that are needing a review.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.The surgeon performed this revision to remedy the patient's condition.This complaint will be closed pending receipt of additional information.No further action is deemed necessary at this time.

• Brand Name: DISC HUM 4X100MM LT FLANGED C
• Type of Device: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 17962379
• MDR Text Key: 326004654
• Report Number: 1644408-2023-01450
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00190446137702
• UDI-Public: 00190446137702
• 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,Followup,Followup
• Report Date: 12/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 540-34-100
• Device Lot Number: 938Y1022
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 49 YR
• Patient Sex: Female