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

Catalog Number	540-34-100
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Joint Laxity (4526)
Date of Event	09/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Revision surgery - due to loosening and infection.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 1644408-2023-01450
• Device Sequence Number: 18097888
• Product Code: JDC
• UDI-Device Identifier: 00190446137702
• UDI-Public: 00190446137702
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K013042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/26/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 540-34-100
• Device Lot Number: 938Y1022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2023
• Supplement Date Received by Manufacturer: 11/06/2023; 12/07/2023
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 11/29/2023; 12/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female