MAUDE Adverse Event Report: TORNIER INC LATITUDE EV ULNAR STEM 70 MM SMALL RIGHT; SEMI-CONSTRAINED CEMENTED ELBOW PROSTHESIS

Catalog Number 0030020

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

Patient Problems Unspecified Infection (1930); Fluid Discharge (2686); Swelling/ Edema (4577)

Event Date 11/25/2021

Event Type  Injury  

Event Description

It was reported that patient (b)(6) had a "surgical debridement rt elbow and excision of sinus tract and synovial biopsies.Intravenous antibiotics post operatively." (re-operation without implant extraction), following a local complication that happened on (b)(6) 2021 ("breakdown of skin over point of elbow with swelling and discharging straw coloured fluid." infection in the operated area resolved without sequelae).

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 "surgical debridement rt elbow and excision of sinus tract and synovial biopsies.Intravenous antibiotics post operatively." (re-operation without implant extraction), following a local complication that happened on (b)(6) 2021 ("breakdown of skin over point of elbow with swelling and discharging straw coloured fluid." infection in the operated area resolved without sequelae).

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.

Manufacturer Narrative

Corrections: refer to g1 reporting entity and reporting contact.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided for evaluation.A device inspection was not possible since the affected device was not returned, and no other evidence was provided for investigation.The batch record could not be reviewed because the affected device was not returned, and the lot number was not communicated.More information as well as the affected device must be available in order to determine the exact root cause of the alleged failure.However, based on the clinical opinion on the potential risk of infection caused by sterile packed stryker implants and instruments, ¿any kind of surgery bears the risk of infection.In trauma and orthopedic surgery with external or internal fixation implants or endoprostheses the infection risk varies between (b)(4), exceptionally up to (b)(4) and beyond, mainly depending on the respective surgical procedure and the typical patient population.¿ a review of the labeling did not indicate any abnormalities.In case the item and / or substantive information will become available in future that suggests otherwise; the file will be reviewed.

Event Description

It was reported that patient (b)(6) had a "surgical debridment rt elbow and excision of sinus tract and synovial biopsies.Intravenous antibiotics post operatively." (re-operation without implant extraction), following a local complication that happened in (b)(6) 2021 ("breakdown of skin over point of elbow with swelling and discharging straw coloured fluid." infection in the operated area resolved without sequelae).

• Brand Name: LATITUDE EV ULNAR STEM 70 MM SMALL RIGHT
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13057011
• MDR Text Key: 285987789
• Report Number: 3004983210-2021-00094
• Device Sequence Number: 1
• Product Code: JDB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K100562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 0030020
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2022
• 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: 81 YR
• Patient Sex: Female
• Patient Weight: 57 KG