MAUDE Adverse Event Report: TORNIER INC TORNIER HRS LOCKING CAP; SHOULDER, PROSTHESIS, REVERSE CONFIGURATION

Catalog Number ARS655200

Device Problem Osseointegration Problem (3003)

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

Event Date 10/18/2023

Event Type  Injury  

Event Description

It was reported that a patient had increased pain due to junctional failure and loosening.Additionally, it was reported: "if the assembly screws and locking cap were not properly torqued, the locking cap loosens and comes out of it¿s spot when the assembly screws starts backing out.The assembly screw is critical for all the components (in this case the proximal body and the distal stem) to stay assembled.So in reality, the distal stem is not the component that disassembled, the entire construct disassembled due to the failure of the assembly screw and locking cap.".

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.

Manufacturer Narrative

The reported event could be confirmed, based on the information provided by user/third party.The device inspection was not possible as the product was not returned for investigation.Since x-ray images were provided, the opinion of a medical expert was sought and stated as following: "about this case.It shows the postoperative status 6 months after the index surgery.Obviously, the surgery was performed for proximal humeral fracture.The x-ray shows a periprosthetic fracture (a) of which we do not know whether it was present before the index surgery, whether is happened intraoperatively, or postoperatively (at an unknown time).The fracture causes insufficient bone support of the proximal body/stem construction.This is amplified by the fact that the tuberosities have not healed to the humeral diaphysis (b).The screw that locks the proximal body to the stem is backing out, most likely because of this insufficient stable bone support and less likely because of insufficient tightening of the screw with inappropriate torque.Yet, a combination of these factors may be into play.Yes, too early playing racket sports before such a periprosthetic fracture has healed is a situation that may jeopardize the fixation of the proximal body to the stem." 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.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.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.If device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

It was reported that a patient had increased pain due to junctional failure and loosening.Additionally, it was reported: "if the assembly screws and locking cap were not properly torqued, the locking cap loosens and comes out of it¿s spot when the assembly screws starts backing out.The assembly screw is critical for all the components (in this case the proximal body and the distal stem) to stay assembled.So in reality, the distal stem is not the component that disassembled, the entire construct disassembled due to the failure of the assembly screw and locking cap.".

• Brand Name: TORNIER HRS LOCKING CAP
• Type of Device: SHOULDER, PROSTHESIS, REVERSE CONFIGURATION
• 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: 18134079
• MDR Text Key: 328109385
• Report Number: 0001649390-2023-00314
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00846832093007
• UDI-Public: 00846832093007
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: ARS655200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2023
• 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): Other