MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSERT SZ 1/2 39MM DIA +0; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWP1390
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was discovered that the artificial shoulder joint insert that was implanted on 2/19 had dislocated from the stem one week after surgery.The scheduled revision date is currently under review.
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Additional Manufacturer Narrative
The reported event could be confirmed, based on the medical expert opinion and since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the visual inspection of the returned device reveals that the alignment tabs appear to be severely damaged.They also exhibit a bit of an upward slope which has compressed the locking ring causing it to be wedged in the locking ring canal.To the area where the identification of the device is etched as "sz 1/2" the edge of the poly above the locking ring is very deformed and gouged.Such condition of the device indicates abnormal and improper handling of the device.Furthermore, a functional test of the returned device was performed with a testing fixature revealed that the device engaged as intended but could be pulled out easily.Therefore, alleged failure could be confirmed.A review of the x-rays by the medical expert stated; ¿the device was used as intended.The metal marker of the insert is not visible and the position between the glenosphere and humeral tray looks in order.The alleged failure of polyethylene insert was however confirmed since the revision surgery was executed, and the device being returned to the manufacturer.¿ a review of 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.A review of the labeling did not indicate any abnormalities.Based on investigation and formal medical expert opinion, the root cause was attributed most likely user related issue.The damaged condition of the device indicates abnormal and improper handling of the device during the surgery.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was discovered that the artificial shoulder joint insert that was implanted on (b)(6) had dislocated from the stem one week after surgery.The scheduled revision date is currently under review.

• Brand Name: PERFORM REV INSERT SZ 1/2 39MM DIA +0
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 18942707
• Report Number: 0001649390-2024-00117
• Device Sequence Number: 2833081
• Product Code: PHX
• UDI-Device Identifier: 00846832084425
• UDI-Public: 00846832084425
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/15/2024

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: DWP1390
• Device Lot Number: 6368AY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2023
• 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 Sex: Male