MAUDE Adverse Event Report: TORNIER INC TORNIER HRS PROXIMAL BODY DIA 13; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	ARS741703
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
Surgeon recently used the revive stem with a pyrocarbon humeral head for a patient who needed to be revised to a hemiarthroplasty.This is off-label usage.
Event or Problem Description
Surgeon recently used the revive stem with a pyrocarbon humeral head for a patient who needed to be revised to a hemiarthroplasty.This is off-label usage.
Additional Manufacturer Narrative
The reported event could be confirmed.Since x-rays were provided, the opinion of the medical expert was requested and stated as following: insufficient bone support of the proximal part of the revive construct may lead to disassembly of the different components of the stem.Also the use of a hemiarthroplasty without an intact rotator cuff may lead to earlier revision (this is not dependent on the use of a pyrocarbon head as such).Based on investigation, the root cause was attributed to a user related issue.The event was caused by an implantation of a configuration of the implants that is not approved in the instruction for use.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 indicates the combinations of tornier hrs with humeral head.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.

• Brand Name: TORNIER HRS PROXIMAL BODY DIA 13
• 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: 20023840
• Report Number: 0001649390-2024-00383
• Device Sequence Number: 8601524
• Product Code: KWS
• UDI-Device Identifier: 00846832092727
• UDI-Public: 00846832092727
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2024

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: ARS741703
• Device Lot Number: AZ1222287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2023
• 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: Required Intervention
• Patient Sex: Unknown