MAUDE Adverse Event Report: TORNIER INC TORNIER HRS PTC DISTAL STEM DIA 11; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number ARS741802

Device Problem Osseointegration Problem (3003)

Patient Problems Inadequate Osseointegration (2646); Implant Pain (4561)

Event Date 04/29/2021

Event Type  Injury  

Manufacturer Narrative

The information in this report was provided by stryker legal affairs department.No additional information is available currently due to the ongoing litigation.The reported event could not be confirmed since the devices were 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.Since elements were provided, the opinion of the medical expert was requested and stated as following: "i concur with the observation that the device list appears to list an excessive number of components for potential implantation in a single shoulder.It is possible that different stems were considered or utilized during the surgery.However, it is regrettable that there is an absence of a description regarding any purported event that may have resulted in a postoperative impact on the patient.Furthermore, there is a lack of additional clinical documentation, such as a surgical report, medical correspondence, or imaging of the shoulder.Regrettably, due to these limitations, i am unable to provide a medical assessment of this case".A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.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 the devices are returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device not available.

Event Description

It was reported in a lawsuit that the patient reported having refractory pain and dysfunction of the shoulder which was refractory to conservative measures.Preoperative imaging was suggestive of loosening of the humeral component, specifically at the junction of the proximal humeral body to the humeral stem at the assembly screw junction.

• Brand Name: TORNIER HRS PTC DISTAL STEM DIA 11
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: 17905770
• MDR Text Key: 325298742
• Report Number: 0001649390-2023-00252
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00846832093021
• UDI-Public: 00846832093021
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/11/2023
• Device Catalogue Number: ARS741802
• Device Lot Number: AZ0818141
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2018
• 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: 59 YR
• Patient Sex: Female