MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSERT SZ 1/2 39MM DIA +3 10 DG; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWR1393
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	01/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: the device has been returned to the manufacturer for evaluation.Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Event or Problem Description
It was reported that the humeral poly has some odd wear that was noticed after it was removed due to a dislocation.This occurred while the surgeon was removing a poly in order to replace it with a thicker poly to deal with instability.
Additional Manufacturer Narrative
The reported event could be confirmed, on the basis of the medical expert opinion.The device inspection revealed the following: the visual inspection of the returned device indicates the scuffed area which is a result of mechanical impingement and/or subluxation/dislocation and are coherent with the described event of dislocation.The hole in the center is left after the screw insertion is made to pull out the polyethylene inlay during the revision surgery.The device history record could not be reviewed because the lot number was not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.A review of the labeling did not indicate any abnormalities.Based on investigation, the root cause was attributed to most likely a patient related issue.The failure was most likely due to insufficient soft-tissue tension.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that the humeral poly has some odd wear that was noticed after it was removed due to a dislocation.This occurred while the surgeon was removing a poly in order to replace it with a thicker poly to deal with instability.

• Brand Name: PERFORM REV INSERT SZ 1/2 39MM DIA +3 10 DG
• 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: 18741173
• Report Number: 0001649390-2024-00058
• Device Sequence Number: 6934008
• Product Code: PHX
• UDI-Device Identifier: 00846832084791
• UDI-Public: 00846832084791
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: DWR1393
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2024
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 76 YR
• Patient Sex: Unknown