MAUDE Adverse Event Report: TORNIER INC TORNIER HRS LOCKING CAP; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	ARS655200
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	11/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could be confirmed, based on the formal medical expert opinion on the available x-rays.The device inspection was not possible as the product was not returned for investigation.A review of the x-rays by the medical expert stated; ¿the device was used as intended.The disassembly or loosening could be confirmed.There are several factors responsible for the loosening, such as an issue with the initial assembly of the device, insufficient stable bone support of the proximal body because of the slow healing of the proximal humeral fracture.¿.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.Based on the available x-ray and formal medical opinion a definitive could not be determined.In order to determine the root cause the implant should have been explanted and made available for investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "operation date (b)(6) 2023.Patient used revive stem with perform reverse.Rep of the case as definitely said there was a locking cap used.The nurse struggling initially with the cap and surgeon themselves tightening the cap.The initial xr the stem was standard.3 month post op the was a gap between proximal body and distal stem (on x-ray).Final xr 7 months po the stem is now joined again.We have inquired whether the patient is feeling these shifts and whether the surgeon would like to go ahead with the revision and asked if they will conduct more xrs under compression and not to see if the implant is shifting.Locking cap was on usage.".

• Brand Name: TORNIER HRS LOCKING CAP
• Common Device Name: 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: 19464072
• Report Number: 0001649390-2024-00246
• Device Sequence Number: 7972984
• Product Code: KWS
• UDI-Device Identifier: 00846832093007
• UDI-Public: 00846832093007
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K030941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2024

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: ARS655200
• Device Lot Number: AZ5221354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown