MAUDE Adverse Event Report: TORNIER INC PERFORM COCR HUMERAL HEAD 43X16; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	DWN4316
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Post Operative Wound Infection (2446)
Date of Event	05/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted if additional information becomes available.
Event or Problem Description
The patient sustained a proximal humerus fracture that was treated with tuberosity repair and hemiarthroplasty.At the time of the procedure, the rotator cuff was confirmed to be intact.Following surgery, the patient was reportedly non-compliant with sling use and non-weight-bearing restrictions, resulting in failure of the fracture repair.The patient did not return for follow-up until a later date, at which time concerns regarding the outcome of the repair were identified.Following positive culture results, the patient requested removal of the hemiarthroplasty and placement of an antibiotic spacer.The surgeon explained the anticipated functional limitations associated with removal of the implant; however, the patient elected to proceed with explantation.The hemiarthroplasty was removed and replaced with an antibiotic spacer.

• Brand Name: PERFORM COCR HUMERAL HEAD 43X16
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 25563777
• Report Number: 0001649390-2026-00576
• Device Sequence Number: 9995946
• Product Code: HSD
• UDI-Device Identifier: 00846832084173
• UDI-Public: 00846832084173
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/19/2026

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: DWN4316
• Device Lot Number: 8471AX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 06/19/2026
• 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: 47 YR
• Patient Sex: Unknown