MAUDE Adverse Event Report: TORNIER INC TORNIER HRS PTC DISTAL STEM DIA 11; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	ARS741802
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device used unknown proximal body ars655101 0mm screw dwf520 tornier flex shoulder sys rev tray 0th 3.5mm offset dwf361c tornier flex shoulder sys rev insert 36mm 6th c 7.5dg dwj401tornier perform reversed stand ard baseplate 25mm unknown glenoid ¿ perform reversed glenoid, (6.5mm screw) dwj012 tornier perform reversed standard glenosphere dia 36mm based on the available information the device remains implanted 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 on a supplemental report.H3 other text : device remains implanted in patient.
Event or Problem Description
It was reported that the patient had pain along the anterior base of the incision.Patient was given an injection - 1ml kenalog, 2ml lidocaine, 7ml ropivacaine.

• Brand Name: TORNIER HRS PTC DISTAL STEM DIA 11
• 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: 18383177
• Report Number: 0001649390-2023-00368
• Device Sequence Number: 7712920
• Product Code: KWS
• UDI-Device Identifier: 00846832093021
• UDI-Public: 00846832093021
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K181420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2023

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: ARS741802
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ARS655101 TORNIER HRS SCREW; DWF361C TORNIER FLEX INSERT; DWF520 TORNIER FLEX TRAY; DWJ12 TORNIER GLENOSPHERE; DWJ401 TORNIER PERFORM BASEPLATE; UNKNOWN GLENOID 6.5 MM SCREW; UNKNOWN PROXIMAL BODY 0MM SCREW
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 56 KG