MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER PERFORM ANATOMIC GLENOID KEELED S30; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWE501
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Granuloma (1876); Loss of Range of Motion (2032); Osteolysis (2377); Inadequate Osseointegration (2646); Implant Pain (4561)
Date of Event	10/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the patient has right shoulder deterioration with increasing pain and reduced mobility the past 1-2 years.Additional imaging revealed glenoid loosening with relatively significant bone loss in relation to a granuloma and lysis of the medical cortex of the humerus.The patient underwent a revision surgery to remove and replace the implant.
Additional Manufacturer Narrative
Correction h6 method code.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: "unfortunately, no pre-revision x-rays were available, yet a report on a pre-revision mri was provided.It discusses loosening and bone resorption around the glenoid component.After 9-years wear of a full polyethylene anatomic glenoid component is possible.The patient reacted with a granulomatous tissue proliferation, something that is seen more often in the presence polyethylene particle debris.Typically, this tissue reaction contributes to osteolysis, explaining the periprosthetic bone loss at both the glenoid and humeral side.Other than this i see no special issues in this case".A review of the device history for the reported lot did not indicate any abnormalities.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.More detailed information about the complaint event as well as the affected device must be available in order to determine clearly the root cause of the complaint event.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the patient has right shoulder deterioration with increasing pain and reduced mobility the past 1-2 years.Additional imaging revealed glenoid loosening with relatively significant bone loss in relation to a granuloma and lysis of the medical cortex of the humerus.The patient underwent a revision surgery to remove and replace the implant.

• Brand Name: TORNIER PERFORM ANATOMIC GLENOID KEELED S30
• 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: 18116035
• Report Number: 3000931034-2023-00437
• Device Sequence Number: 7016155
• Product Code: KWS
• UDI-Device Identifier: 03700434021615
• UDI-Public: 03700434021615
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2024

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 Expiration Date: 09/30/2019
• Device Catalogue Number: DWE501
• Device Lot Number: 8382AO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 11/10/2023
• Supplement Report FDA Received Date: 02/09/2024
• 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: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 51 KG