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

Model Number	DWE503
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle/Tendon Damage (4532); Implant Pain (4561)
Date of Event	01/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed. a review of the device history is not possible because the lot number was not communicated. should additional information become available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the patient noticed pain after physical therapy post-operative rotator cuff tear.The mri shows a lesser tuberosity avulsion and subscapularis tear.The patient underwent an open rotator cuff repair with superior cuff reconstruction using arthoflex allograft.The event was resolved without sequelae.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Since data were provided, the opinion of a medical expert was sought and stated as following: "to be able to assess this case the availability of the mri-images (and/or a report) would prove very helpful, as well as a report of both surgeries (.) because "the conflicting information in the ae description is that the mri showed a subscapularis tendon rupture and a lesser tuberosity avulsion (that is both at the anterior side of the shoulder), and that the surgeon had to repair the superior cuff (that is the supraspinatus tendon and parts of the infraspinatus tendon)", and also because "(.) an early postoperative mri is not very reliable for the detection of smaller lesions, because of these unavoidable artifacts.Only larger lesions with tendon retraction can be diagnosed more reliably on an early postoperative mri".Moreover, "we cannot be sure of the reason [why the patient noticed pain after physical therapy before been re-operated].The exercises may play a role in the event".It "depends on the additional information on status of the rotator cuff during the re-operation".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 noticed pain after physical therapy post-operative rotator cuff tear.The mri shows a lesser tuberosity avulsion and subscapularis tear.The patient underwent an open rotator cuff repair with superior cuff reconstruction using arthoflex allograft.The event was resolved without sequelae.

• Brand Name: TORNIER PERFORM ANATOMIC GLENOID KEELED S40
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin TN 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin TN 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14633198
• Report Number: 3000931034-2022-00245
• Device Sequence Number: 3626236
• Product Code: KWS
• UDI-Device Identifier: 03700434019186
• UDI-Public: 03700434019186
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2022

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 Model Number: DWE503
• Device Catalogue Number: DWE503
• 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: 05/12/2022
• Supplement Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 08/26/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 104 KG