MAUDE Adverse Event Report: TORNIER S.A.S. D.4,5MM COMPRESSION SCREW L.18MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number VDV118

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Fluid Discharge (2686)

Event Date 10/21/2022

Event Type  Injury  

Event Description

It was reported that there was a shoulder replacement.The patient reported oozing of the wound post-procedure.An exploration surgery and culture revealed the presence of an infection.The first stage of the revision was completed with a wash out.

Manufacturer Narrative

Pma/510k: the event involves a device that is not cleared for sale in the u.S., but a similar device (# vdv218) is commercially available cleared under 510k # k030941.Device is not available for evaluation as it was discarded and is not available for return.If additional information becomes available, it will be provided on a supplemental report.

Manufacturer Narrative

Please note the correction to the d4 lot #: the reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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 as well as the affected device 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 Description

It was reported that there was a shoulder replacement.The patient reported oozing of the wound post-procedure.An exploration surgery and culture revealed the presence of an infection.The first stage of the revision was completed with a wash out.

• Brand Name: D.4,5MM COMPRESSION SCREW L.18MM
• Type of Device: 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): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15815806
• MDR Text Key: 303830674
• Report Number: 3000931034-2022-00375
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: VDV118
• Device Lot Number: 5398AX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male