MAUDE Adverse Event Report: TORNIER INC PERFORM LOW OFFSET HUMERAL HEAD COUPLER TI; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWT110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	10/29/2024
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
Subject: (b)(6) perform humeral system (phs) study.Post-operative adverse event: bilateral pulmonary embolism (pe) adverse event description: sob (shortness of breath) for 3 weeks, d-dimer 21536.Study device: not related.Surgical procedure: causal relationship.Is this a serious adverse event (sae)? : yes.Medication: dalteparin, ctpa, apixaban.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned.Since x-ray was provided, the opinion of the medical expert was sought and stated as follows: pulmonary embolism is not related to the study device and most likely related to the surgical procedure.The stem is uncemented and thereby no specific additional risk factor for embolisms seems to be introduced.No factor that could have contributed to the reported event could be determined form the available information.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.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Subject: (b)(6) perform humeral system (phs) study.Post-operative adverse event: bilateral pulmonary embolism (pe).Adverse event description: sob (shortness of breath) for 3 weeks, d-dimer 21536.Study device: not related.Surgical procedure: causal relationship.Is this a serious adverse event (sae)? yes.Medication: dalteparin, ctpa, apixaban.

• Brand Name: PERFORM LOW OFFSET HUMERAL HEAD COUPLER TI
• 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 S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23536644
• Report Number: 0001649390-2025-00814
• Device Sequence Number: 15724370
• Product Code: KWS
• UDI-Device Identifier: 00846832085095
• UDI-Public: (01)00846832085095(11)230613(17)280613(21)3795AZ001
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2026

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: DWT110
• Device Lot Number: 3795AZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2023
• 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: Other
• Patient Age: 65 YR
• Patient Sex: Unknown
• Patient Weight: 115 KG