MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSERT SZ 3/4, 42MM DIA, +0 VE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED

Model Number DWS2420

Device Problems Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Joint Laxity (4526)

Event Date 04/18/2023

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

It was reported that the patient had subjective instability.Patient states feeling that the shoulder "popped out" and has to wait to resume activity.

Event Description

It was reported that the patient had subjective instability.Patient states feeling that the shoulder "popped out" and has to wait to resume activity.

Manufacturer Narrative

The reported event could not be confirmed.The device remains implanted and no other evidence was provided that could confirm the allegation.A device inspection was not possible since the affected device was not returned as it remains implanted in the patient.A review of the labeling and the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.More information as well as the affected device must be available in order to determine the exact root cause of the alleged failure.If any additional information is provided, the investigation will be reassessed.

• Brand Name: PERFORM REV INSERT SZ 3/4, 42MM DIA, +0 VE
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, 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: 16950444
• MDR Text Key: 315438375
• Report Number: 0001649390-2023-00099
• Device Sequence Number: 1
• Product Code: PAO
• UDI-Device Identifier: 00846832078110
• UDI-Public: 00846832078110
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DWS2420
• Device Catalogue Number: DWS2420
• Device Lot Number: CZ6122129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2022
• 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): Other
• Patient Age: 57 YR
• Patient Weight: 82 KG