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

Model Number	DWB217
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Osteolysis (2377); Implant Pain (4561)
Date of Event	06/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.When additional information becomes available, it will be provided on a supplemental report.Device discarded/disposed by scrub nurse.
Event or Problem Description
Patient presented to surgeon several months ago with increasing pain in prosthetic shoulder joint.Patient underwent removal of anatomic shoulder replacement prosthesis due to rotator cuff tendon degeneration and loosening of glenoid component.Glenoid component became loose due to osteolysis behind the component, according to surgeon.A reverse shoulder replacement prosthesis was subsequently implanted.
Event or Problem Description
Patient presented to surgeon several months ago with increasing pain in prosthetic shoulder joint.Patient underwent removal of anatomic shoulder replacement prosthesis due to rotator cuff tendon degeneration and loosening of glenoid component.Glenoid component became loose due to osteolysis behind the component, according to surgeon.A reverse shoulder replacement prosthesis was subsequently implanted.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.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.If the device is returned or any further information is provided, the complaint report will be updated.

• Brand Name: AEQUALIS PEGGED GLENOID
• 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: 15048475
• Report Number: 3000931034-2022-00260
• Device Sequence Number: 4667854
• Product Code: KWS
• UDI-Device Identifier: 03700386915475
• UDI-Public: 03700386915475
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K060209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/14/2019
• Device Model Number: DWB217
• Device Catalogue Number: DWB217
• Device Lot Number: 4842AO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2014
• 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; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Male