MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS REVINSERT 42MM 6TH B 12.5DG; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWF421B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	06/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "pt underwent primary right reverse shoulder replacement, on (b)(6) 2024.Pt experienced recent history of pain, swelling, in right prosthetic shoulder joint.Underwent revision on (b)(6) 2024.Multiple specimens taken, to determine if infection present - glenoid component, and humeral tray and poly revised.Pt underwent a 2nd revision, on (b)(6) 2024, due to significant swelling in prosthetic joint.Wound opened, to reveal large collection of hematoma.No obvious collection of pus.Humeral tray / poly again revised, as well as the glenosphere.Multiple specimens again taken.Copious lavage".
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence were provided.A device inspection was not possible since the affected device was not returned for investigation.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.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "pt underwent primary right reverse shoulder replacement, on (b)(6) 2024.Pt experienced recent history of pain, swelling, in right prosthetic shoulder joint.Underwent revision on (b)(6) 2024.Multiple specimens taken, to determine if infection present, glenoid component, and humeral tray and poly revised.Pt underwent a 2nd revision, on (b)(6), due to significant swelling in prosthetic joint.Wound opened, to reveal large collection of hematomata.No obvious collection of pus.Humeral tray / poly again revised, as well as the glenosphere.Multiple specimens again taken.Copious lavage".

• Brand Name: TORNIER FLEX SHOULDER SYS REVINSERT 42MM 6TH B 12.5DG
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19723103
• Report Number: 3000931034-2024-00379
• Device Sequence Number: 8328311
• Product Code: KWS
• UDI-Device Identifier: 03700434021516
• UDI-Public: 03700434021516
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2024

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: DWF421B
• Device Lot Number: AG6774
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2024
• 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 Age: 70 YR
• Patient Sex: Male