MAUDE Adverse Event Report: TORNIER INC UNKNOWN LATITUDE EV ANATOMIC HUMERAL SPOOL; SEMI-CONSTRAINED CEMENTED ELBOW PROSTHESIS

Catalog Number UNK_WTM

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

Patient Problems Pain (1994); Discomfort (2330)

Event Date 12/07/2021

Event Type  Injury  

Manufacturer Narrative

The device will not be returned as it remains implanted.If additional information becomes available, it will be provided in a supplemental report.

Event Description

It was reported that patient (b)(6) had a post-operative complication due to abnormal or persistent pain, defined as "ongoing persistent pain elbow, discomfort at wrist and hand", 3 months after primary surgery.Ae outcome: ongoing - additional information: patient keen to avoid further surgery hence 'watch & wait' approach to persistent pain.All investigations normal.

• Brand Name: UNKNOWN LATITUDE EV ANATOMIC HUMERAL SPOOL
• Type of Device: SEMI-CONSTRAINED CEMENTED ELBOW PROSTHESIS
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: janice mithouard ; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330 ; 476613500
• MDR Report Key: 13122345
• MDR Text Key: 285676384
• Report Number: 3004983210-2021-00100
• Device Sequence Number: 1
• Product Code: JDB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K070787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_WTM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2021
• 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): Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 68 KG