MAUDE Adverse Event Report: BIOMET UK LTD. IBP ULNA LEFT STD INTLK; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Cyst(s) (1800)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: medical product: custom lt ibp med humeral comp, catalog #: cp560539, lot #: 750420.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial elbow arthroplasty on (b)(6) 2002.Subsequently underwent a procedure in 2011 for triceps" blackened cyst".No additional information is available from the event.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that the patient underwent an initial elbow arthroplasty.Subsequently underwent a procedure for triceps" blackened cyst".No additional information is available from the event.

• Brand Name: IBP ULNA LEFT STD INTLK
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8439217
• MDR Text Key: 139414388
• Report Number: 3002806535-2019-00294
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 114368
• Device Lot Number: 221552
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 68