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

Model Number	DWB210
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Fall (1848); Inadequate Osseointegration (2646); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2022
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.Device disposition is unknown.
Event or Problem Description
It was reported there was a revision of an old total shoulder.During revision they had a humeral shaft fracture.Additionally, it was reported; the procedure was extended by 2 hours.
Event or Problem Description
It was reported there was a revision of an old total shoulder.During revision they had a humeral shaft fracture.Additionally, it was reported; the procedure was extended by 2 hours.The patient may have had a fall initially and this loosened the glenoid component.Then it started to move more and eventually failed.
Additional Manufacturer Narrative
Please note the correction regarding the h6 (device and clinical code): the reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided for evaluation.A device inspection was not possible since the affected device was not returned, and no other evidences were provided for investigation.The batch record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.More information as well as the affected device must be available in order to determine the exact root cause of the alleged failure.If any additional information is provided, the investigation will be reassessed.

• Brand Name: AEQUALIS KEELED GLENOID SMALL
• 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: 16102138
• Report Number: 3000931034-2023-00002
• Device Sequence Number: 7636828
• Product Code: KWS
• UDI-Device Identifier: 03700386915413
• UDI-Public: 03700386915413
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K994393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2023

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: DWB210
• Device Catalogue Number: DWB210
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2022
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 04/10/2023
• 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: 62 YR
• Patient Sex: Female