MAUDE Adverse Event Report: TORNIER INC LATITUDE TOTAL ELBOW HUMERAL SPOOL MEDIUM CENTERED OFF RIGHT; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Catalog Number	DKY213
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Cramp(s) /Muscle Spasm(s) (4521); Implant Pain (4561)
Date of Event	04/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
As reported: "welbow subject (b)(6).One-month post-surgery involving the total latitude implant, the patient experienced persistent and abnormal pain, accompanied by heightened stiffness.Notably, there is a marked reduction in the patient's range of motion, with increased vigilance required due to the emergence of aggressive muscle contractions in the brachio-radial muscle.Furthermore, there is a pronounced rigidity observed during flexion, emphasizing the need for close monitoring and prompt intervention.To address this issue effectively, a comprehensive rehabilitation program featuring gentle kinetherapy and targeted muscle massage were prescribed.Additionally, a procedure involving the removal of the splint at a 90° flexion angle was carried out to augment the overall treatment strategy.This event was resolved without sequelae.".

• Brand Name: LATITUDE TOTAL ELBOW HUMERAL SPOOL MEDIUM CENTERED OFF RIGHT
• Common Device Name: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
• 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: 18610599
• Report Number: 0001649390-2024-00024
• Device Sequence Number: 7565555
• Product Code: JDC
• UDI-Device Identifier: 00846832011131
• UDI-Public: 00846832011131
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K171010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/30/2024

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: Lay User/Patient
• Device Catalogue Number: DKY213
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 01/30/2024
• 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: Other
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 65 KG