MAUDE Adverse Event Report: TORNIER INC UNKNOWN_WRIGHT TORNIER-MONTBONNOT_PRODUCT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number UNK_WTM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Limb Fracture (4518)

Event Date 11/30/2022

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 there was a revision of an old ascend total shoulder.Large glenoid defect.Extraction of the cemented humeral stem was difficult.Resulted in a proximal transverse humeral shaft fracture.Was plated and wired and a revive stem placed.Glenoid was bone grafted and converted to a reverse shoulder using the perform plus reverse full wedge.The proximal humeral fracture resulted in an approximate 2 hour increase in surgical time.On a later date, it was noted that the patient may have had a fall initially and this loosened the glenoid component.Then it started to move more and eventually failed.

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided for evaluation.A device inspection was not possible since the affected device was not returned, and no other evidences were provided for investigation.The batch 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 information as well as the affected device must be available in order to determine the exact root cause of the alleged failure.If any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that there was a revision of an old ascend total shoulder.Large glenoid defect.Extraction of the cemented humeral stem was difficult.Resulted in a proximal transverse humeral shaft fracture.Was plated and wired and a revive stem placed.Glenoid was bone grafted and converted to a reverse shoulder using the perform plus reverse full wedge.The proximal humeral fracture resulted in an approximate 2 hour increase in surgical time.On a later date, it was noted that the patient may have had a fall initially and this loosened the glenoid component.Then it started to move more and eventually failed.

• Brand Name: UNKNOWN_WRIGHT TORNIER-MONTBONNOT_PRODUCT
• 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: 16064212
• MDR Text Key: 306315809
• Report Number: 0001649390-2022-00119
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_WTM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2023
• 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
• Patient Age: 62 YR
• Patient Sex: Female