MAUDE Adverse Event Report: TORNIER INC LATITUDE ULNAR STEM 75 MMMEDIUM LEFT; PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

Catalog Number	0030121
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Loss of Range of Motion (2032); Inadequate Osseointegration (2646); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	09/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, the patient underwent open reduction, internal fixation of fractured left distal humerus, in 2017.She underwent total elbow replacement on (b)(6) 2017, using tornier latitude ter implants.She has been very happy with this surgery until recent months but later presented with painful left elbow, decreased range of motion, swelling.X-rays suggestive of possible infection and loosening.Surgery failed due to infection.During surgery today, gross amount of synovitis tissue was found, and excised.Ulnar components were frankly loose and removed by the surgeon using his fingers only.Multiple tissue specimens were taken.Humeral components were still well fixed, but with osteolysis around the distal part of the prosthesis.Surgeon decided to remove this component (which was well fixed), clean out both medullary canals, copious lavage, and implant revision sized extra-long components.As reported, explanted components are available for return.Both revision components cemented in using antibiotic cement.Joint stable on reduction and wound closed.Surgeon performed this, 1-stage revision arthroplasty because of multiple co-morbidities that the patient suffers from, which require urgent treatment, chemotherapy.No other information is provided.
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that, the patient underwent open reduction, internal fixation of fractured left distal humerus, in 2017.She underwent total elbow replacement on (b)(6) 2017, using tornier latitude ter implants.She has been very happy with this surgery until recent months but later presented with painful left elbow, decreased range of motion, swelling.X-rays suggestive of possible infection and loosening.Surgery failed due to infection.During surgery today, gross amount of synovitis tissue was found, and excised.Ulnar components were frankly loose and removed by the surgeon using his fingers only.Multiple tissue specimens were taken.Humeral components were still well fixed, but with osteolysis around the distal part of the prosthesis.Surgeon decided to remove this component (which was well fixed), clean out both medullary canals, copious lavage, and implant revision sized extra-long components.As reported, explanted components are available for return.Both revision components cemented in using antibiotic cement.Joint stable on reduction and wound closed.Surgeon performed this, 1-stage revision arthroplasty because of multiple co-morbidities that the patient suffers from, which require urgent treatment, chemotherapy.No other information is provided.
Additional Manufacturer Narrative
The reported event could not be confirmed since an evaluation of the provided evidence and returned devices cannot confirm presence of infection.Additionally, no pathology reports were provided.The device inspection revealed the following: an evaluation of the provided x-rays shows that there is loosening of the ulnar component and some osteolysis at the far distal end of the bone around the humeral implant, and without pathology reports the alleged failure mode cannot be confirmed.Additionally, an evaluation of the sterilization records of the device was evaluated by a stryker microbiologist and were found to be within specifications.Based on investigation, the root cause was attributed to a patient related issue.The event was caused by poor bone quality; this has been confirmed by a stryker hcp which evaluated all provided evidence.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.

• Brand Name: LATITUDE ULNAR STEM 75 MMMEDIUM LEFT
• Common Device Name: PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23265553
• Report Number: 0001649390-2025-00709
• Device Sequence Number: 21371009
• Product Code: JDB
• UDI-Device Identifier: 00846832002580
• UDI-Public: (01)00846832002580(17)190920
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K171010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/20/2019
• Device Catalogue Number: 0030121
• Device Lot Number: CC0116209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/12/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 10/10/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2016
• 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: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 90 KG