MAUDE Adverse Event Report: TORNIER INC UNKNOWN PERFORM REVERSED SPHERE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number UNK_WTB

Device Problem Osseointegration Problem (3003)

Patient Problems Stroke/CVA (1770); Inadequate Osseointegration (2646)

Event Date 06/14/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, a revision surgery was performed by dr.(b)(6), utilizing the blueprint planning feature.The system that underwent revision was ascend flex with perform reversed.In this procedure, the original ascend flex stem was retained while the tray and poly were replaced.Additionally, the baseplate, screws, and sphere were removed and exchanged.Following the surgery, the patient experienced a stroke.The surgeon suspects that the patient's arm was pulled on by hospital staff members during assistance with transferring, which caused the baseplate and sphere to come loose and be improperly positioned.Notably, no x-rays were taken, only a blueprint ct scan was available.There were no other remarkable circumstances related to the event, such as additional trauma, disease, or delayed/non-union issues.

Manufacturer Narrative

The reported event was confirmed through the evaluation of a medical expert.Since data was provided, the opinion of a medical expert was sought and stated as follows: "yes, i believe pulling the patient's arm may have been a contributing factor in this event, especially if it involved the paralytic arm, where the muscles would not be able to guard the joint.The blueprint images show from the glenoid bone imprint of the baseplate, that the baseplate was atypically positioned relatively superiorly and posteriorly, possibly making the initial fixation less optimal." more detailed information about the complaint event as well as the affected device must be available in order to determine the exact root cause of the complaint event.A possible root cause, as noted by the medical expert review, of less-than-optimal position of the prosthesis during implantation can be assessed from the provided blueprint images.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition is unknown.

• Brand Name: UNKNOWN PERFORM REVERSED SPHERE
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER 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: 17469064
• MDR Text Key: 320481949
• Report Number: 0001649390-2023-00179
• 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
• Report Date: 08/07/2023

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_WTB
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/11/2023
• Initial Date FDA Received: 08/07/2023
• 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