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

Catalog Number	0030121
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Inadequate Osseointegration (2646)
Date of Event	02/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Event or Problem Description
During a surgical procedure, the #5 flexible reamer broke while being used on a patient's elbow.Both pieces of the reamer were retrieved, and an x-ray was taken, which showed no abnormalities.The original intended procedure was the removal of hardware from the right elbow, insertion of a cement antibiotic spacer, irrigation and debridement of the right elbow, and bursectomy of the olecranon bursa.The user encountered problems related to device failure and malfunction.
Additional Manufacturer Narrative
Corrections: device code, clinical signs code: the reported event was confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: a visual examination of the device reveals wear, shearing, and divots in the poly bushing of the ulnar stem.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.The investigation determined that patient factors were the root cause, with the healthcare provider performing the revision surgery indicating that the patient's weight caused excessive mechanical loading on the implant.The revision surgery targeted not the metal portion of the ulnar stem, but rather the poly bushing, which was confirmed to be damaged.Without x-rays or additional information provided by the healthcare provider, the loosening of the metal stem cannot be confirmed.If more information is provided, the case will be reassessed.
Event or Problem Description
During a surgical procedure, the #5 flexible reamer broke while being used on a patient's elbow.Both pieces of the reamer were retrieved, and an x-ray was taken, which showed no abnormalities.The original intended procedure was the removal of hardware from the right elbow, insertion of a cement antibiotic spacer, irrigation and debridement of the right elbow, and bursectomy of the olecranon bursa.The user encountered problems related to device failure and malfunction.

• Brand Name: LATITUDE EV ULNAR STEM 75 MM MEDIUM LEFT
• Common Device Name: PROSTHESIS, ELBOW, SEMI-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: 18822906
• Report Number: 0001649390-2024-00081
• Device Sequence Number: 4462720
• Product Code: JDB
• UDI-Device Identifier: 00846832002580
• UDI-Public: 00846832002580
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K100562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

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: 0030121
• Device Lot Number: CC0218338020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 07/08/2024
• 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: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 166 KG