MAUDE Adverse Event Report: ENCORE MEDICAL L.P SR MCP, IMPLANT SIZE X-LARGE; SEMI-CONSTRAINED METAL/POLYMER FINGER JOINT PROSTHESIS

Model Number 5800-XL00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

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 - implanted size xl proximal and distal, distal rotated and set in the cement.Had to remove and only available distal component was a size lg.Ended up with a xl proximal implant and lg distal implant.

Manufacturer Narrative

The agent reported "(implanted size xl proximal and distal, distal rotated and set in the cement.Had to remove and only available distal component was a size lg.Ended up with a xl proximal implant and lg distal implant.Surgeon was happy with original implant (was a revision procedure) was an equivalent lg pyrocarbon)." there was no previous dticket provided, therefore, the time in vivo could be determined and the listed items could not be verified.Note: the lot number was corrected from the original report which reported an incomplete lot number.This evaluation is limited in scope as the item(s) associated with this investigation was not returned to djo surgical - austin for examination.The surgery was completed as intended.Received additional information from the lmt team regarding this case: is the explant available for investigation? no.Is the event reportable? we consider this to be a reportable event.Is there any information about the patient or the location of implantation? the implant was in the middle finger right hand mcp joint.Do you have x-rays or surgeon reports? no x-rays are available.Surgeon was happy with outcome at the time and have not heard anything since the procedure.If any other additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.There was no 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.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.Deviation, nonconformance (b)(4): mfgpro showed index aa whereas the technical drawing in onplm was released under index b.Correction: ref (b)(4) lot 16694g was manufactured according to technical drawing (b)(4).Customer complaint history of the reported device(s) 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 the distal rotated and set in the cement.No 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.

• Brand Name: SR MCP, IMPLANT SIZE X-LARGE
• Type of Device: SEMI-CONSTRAINED METAL/POLYMER FINGER JOINT PROSTHESIS
• 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: 17339276
• MDR Text Key: 319288115
• Report Number: 1644408-2023-00920
• Device Sequence Number: 1
• Product Code: MPK
• UDI-Device Identifier: 00886385021072
• UDI-Public: 00886385021072
• Combination Product (y/n): N
• 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
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5800-XL00
• Device Catalogue Number: 5800-XL00
• Device Lot Number: 16649G
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• 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): Other; Required Intervention