MAUDE Adverse Event Report: TORNIER INC UNKNOWN PERFORM REVERSED BASEPLATE; 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  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.H3 other text : device disposition is unknown.

Event Description

On (b)(6) 2023, a revision surgery took place, utilizing the blueprint planning feature (case id: (b)(4)).The attached blueprint planning report outlines the details of the procedure.Subsequent to the surgery, a stroke occurred in the patient.It is postulated that the patient's arm underwent pulling forces by hospital staff during transfers, resulting in complications.Consequently, both the baseplate and sphere became dislodged from their intended positions.In response to this incident, the decision was made to extract and replace the baseplate, screws, and sphere (perform reversed).The original ascend flex stem remained in situ, while the tray and poly (tornier flex) were substituted.Notably, no x-rays were taken; rather, a blueprint ct scan was employed.No exceptional circumstances, such as additional trauma, underlying medical conditions, or issues like delayed or non-union, were identified in relation to the aforementioned event.

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 belief pulling the patients 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.

Event Description

On 14-jun-2023, a revision surgery took place, utilizing the blueprint planning feature (case id: (b)(4)).The attached blueprint planning report outlines the details of the procedure.Subsequent to the surgery, a stroke occurred in the patient.It is postulated that the patient's arm underwent pulling forces by hospital staff during transfers, resulting in complications.Consequently, both the baseplate and sphere became dislodged from their intended positions.In response to this incident, the decision was made to extract and replace the baseplate, screws, and sphere (perform reversed).The original ascend flex stem remained in situ, while the tray and poly (tornier flex) were substituted.Notably, no x-rays were taken; rather, a blueprint ct scan was employed.No exceptional circumstances, such as additional trauma, underlying medical conditions, or issues like delayed or non-union, were identified in relation to the aforementioned event.

• Brand Name: UNKNOWN PERFORM REVERSED BASEPLATE
• 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: 17469209
• MDR Text Key: 320485991
• Report Number: 0001649390-2023-00180
• 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: 08/30/2023

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/11/2023
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: 08/04/2023
• Supplement Dates FDA Received: 08/30/2023
• 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