MAUDE Adverse Event Report: TORNIER INC PERFORM HUMERAL +9MM SPACER SZ3/4; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED

Catalog Number	DWX934
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted if additional information becomes available.
Event or Problem Description
It was reported that this is the patient¿s second disassociation, and on this occasion the patient claims they woke up in the morning with the joint dislocated.
Additional Manufacturer Narrative
The reported event was confirmed.The devices were returned for evaluation and the condition of the returned devices aligned with the event as noted in this complaint.A visual inspection revealed the returned spacer to have considerable damage.There are scuffs around nearly 25% of the outer rim of the device over the laser etch portion.Significant gouges appear on the underside in three spots on the circumference of the device that are equal in size.Superficial scratches appear on the morse taper.At the underside of the morse taper there is heavy discoloration.There is also a small region of damage to the lock ring groove on the lateral portion of the complaint spacer: 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.After extensive review and functional testing of the returned device, failure cannot be conclusively determined.It is possible that the reported patient fall in pi (b)(6) caused the insert to dislodge and damaged the spacer lock ring groove in the process.This subsequent dissociation of the insert from this same spacer could potentially be explained by the aforementioned spacer damage since this spacer was retained during the first revision.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that this is the patient¿s second disassociation, and on this occasion the patient claims they woke up in the morning with the joint dislocated.

• Brand Name: PERFORM HUMERAL +9MM SPACER SZ3/4
• Common Device Name: 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22877881
• Report Number: 0001649390-2025-00586
• Device Sequence Number: 20255864
• Product Code: PAO
• UDI-Device Identifier: 00846832085538
• UDI-Public: (01)00846832085538(11)230626(17)280626(21)5101AZ012
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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: DWX934
• Device Lot Number: 5101AZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2023
• 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: Required Intervention
• Patient Sex: Unknown