MAUDE Adverse Event Report: TORNIER INC UNKNOWN GLENOID; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Catalog Number UNK_WTB

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Dislocation (2374)

Event Date 06/22/2023

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device disposition is unknown.

Event Description

It was reported that a patient's non-compliance led to a dislocation.The plan was to go back in and do a poly swap, but when the surgeon opened the patient, the stem did not have sufficient bony ingrowth (again, compliance issue bc the patient did not adhere to post op instructions of no lifting.Hence stem not given sufficient time for bony ingrowth).The surgeon decided that moving to a distal fitting stem like revive would help alleviate this issue.Upon trailing the stem, tray, and poly of the revive system, the surgeon felt the glenosphere needed to be sized down for greater range of motion.The glenosphere change was to get greater range of motion with the stem change.

Manufacturer Narrative

Please note the correction made to the h6 device code: the reported event was not 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.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 Description

It was reported that a patient's non-compliance led to a dislocation.The plan was to go back in and do a poly swap, but when the surgeon opened the patient, the stem did not have sufficient bony ingrowth (again, compliance issue bc the patient did not adhere to post op instructions of no lifting.Hence stem not given sufficient time for bony ingrowth).The surgeon decided that moving to a distal fitting stem like revive would help alleviate this issue.Upon trialing the stem, tray, and poly of the revive system, the surgeon felt the glenosphere needed to be sized down for greater range of motion.The glenosphere change was to get greater range of motion with the stem change.

• Brand Name: UNKNOWN GLENOID
• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
• 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: 17354938
• MDR Text Key: 319341241
• Report Number: 0001649390-2023-00171
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_WTB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/27/2023
• 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): Required Intervention