MAUDE Adverse Event Report: TORNIER INC UNKNOWN LATITUDE ULNAR BUSHING; PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

Model Number	DKY120
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	06/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the patient underwent a revision of a latitude elbow whereby the radial component had loosened over 15 years, causing pain.The revision consisted of removing the radial components and then changing a poly liner.Finally the implant was constrained using an ulnar cap.
Additional Manufacturer Narrative
Correction: d1, d4 part and lot 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 catalog number and lot number were 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
It was reported that the patient underwent a =revision of a latitude elbow whereby the radial component had loosened over 15 years, causing pain.The revision consisted of removing the radial components and then changing a poly liner.Finally the implant was constrained using an ulnar cap.

• Brand Name: UNKNOWN LATITUDE ULNAR BUSHING
• 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: 17259120
• Report Number: 0001649390-2023-00160
• Device Sequence Number: 7882096
• Product Code: JDB
• UDI-Device Identifier: 00846832010974
• UDI-Public: 00846832010974
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K100562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2023

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 Model Number: DKY120
• Device Catalogue Number: UNK_WTB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 08/25/2023
• 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: 60 YR
• Patient Sex: Female