MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED CTR SCREW 6.5MMX40MM STERILE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWJ540
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	08/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, the conversion of reverse total shoulder arthroplasty to hemiarthroplasty was performed.Second revision of perform humeral stem and perform reverse glenoid for chronic dislocation (instability).Index surgery done in usa.The patient dislocated again 4 weeks after the revision done on (b)(6) 2025 (oa 1156009).The perform reverse 42 + 4mm eccentric glenosphere, 4 x peripheral screws, +3mm lateralised baseplate and 40mm x 6.5mm central screw were explanted.The 10 degree 42mm retentive +6mm liner was explanted and the humeral prosthesis was converted to a hemi-arthroplasty with a centred humeral head coupler and 43 x 16mm perform humeral head.
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the 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.The device inspection was not possible as the product was not returned for investigation.From the provided picture taken just after the devices explantation (soiled implants), no additional information could be observed.The device history record could not be reviewed because the affected device was not returned, and 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.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 further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that, the conversion of reverse total shoulder arthroplasty to hemiarthroplasty was performed.Second revision of perform humeral stem and perform reverse glenoid for chronic dislocation (instability).Index surgery done in usa.The patient dislocated again 4 weeks after the revision done on (b)(6) 2025 (oa 1156009).The perform reverse 42 + 4mm eccentric glenosphere, 4 x peripheral screws, +3mm lateralised baseplate and 40mm x 6.5mm central screw were explanted.The 10 degree 42mm retentive +6mm liner was explanted and the humeral prosthesis was converted to a hemi-arthroplasty with a centred humeral head coupler and 43 x 16mm perform humeral head.

• Brand Name: TORNIER PERFORM REVERSED CTR SCREW 6.5MMX40MM STERILE
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23028206
• Report Number: 0001649390-2025-00650
• Device Sequence Number: 13118633
• Product Code: PHX
• UDI-Device Identifier: 00846832091126
• UDI-Public: 00846832091126
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K161742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: DWJ540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 64 YR
• Patient Sex: Male