MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER PERFORM ANATOMIC GLENOID PEGGED S40; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWE303
Medical Device Problem Codes	Material Erosion (1214); Loss of Osseointegration (2408); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device remains implanted in patient.
Event or Problem Description
It was reported that the patient had a glenoid component loosening 4 years after primary surgery.X-rays show increased anterior and superior glenoid erosion and lucency action taken: patient opted for conservative care at this time adverse event outcome : ongoing.
Additional Manufacturer Narrative
Correction: h6 device code.The reported event could not be confirmed since the device was not returned for evaluation.However, the tornier shoulder outcomes study for this patient was available.This document was reviewed by the medical expert.The opinion of the medical expert state as following: "the female patient with a healthy weight and no co-morbidities that may influence the outcome, received an anatomic shoulder replacement of the right shoulder on (b)(6) 2017.The indication was primary osteoarthritis with an intact rotator cuff, mild glenohumeral degeneration and concentric wear of the native glenoid.The shoulder was replaced by the combination of a uncemented simplicity 43x16 mm humeral component in combination with a s40 perform pegged (partially) cemented glenoid component.At 1&2-year follow up the patient was very satisfied with the outcome.The file doesn¿t report on the x-ray follow-up at those times.The adverse event was reported on (b)(6) 2022 as component loosening, described as: x-rays show increased anterior and superior glenoid erosion and lucency.For this medical opinion, the images were not available for reviewing.In my opinion there a no medical or health-reasons involved in this adverse event.Other factors such as implant positioning, change of implant positioning, clues for rotator cuff degeneration and/or altered joint mechanics and third body wear explaining possible accelerated glenoid component wear, cannot be assessed at this time.For that, the x-rays must be reviewed." 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.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the patient had a glenoid component loosening 4 years after primary surgery.X-rays show increased anterior and superior glenoid erosion and lucency action taken: patient opted for conservative care at this time adverse event outcome : ongoing.

• Brand Name: TORNIER PERFORM ANATOMIC GLENOID PEGGED S40
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13624954
• Report Number: 3000931034-2022-00123
• Device Sequence Number: 5125376
• Product Code: KWS
• UDI-Device Identifier: 03700434019308
• UDI-Public: 03700434019308
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K111902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: DWE303
• Device Catalogue Number: DWE303
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 59 KG