MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED GLENOSPHERE CENTERED 42 MM X 29MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number DWD193

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Date 09/07/2022

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device discarded by scrub nurse.

Event Description

It was reported that a patient underwent reverse shoulder replacement on (b)(6) 2019.Patient has had a long standing history of wound infection, which has required multiple re-operations for wound washout and change of poly.Surgery yesterday also resulted in exchange of humeral poly and also the glenosphere on this occasion, with copious lavage.Multiple tissue specimens taken.

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 in order 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 if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that a patient underwent reverse shoulder replacement on (b)(6) 2019.Patient has had a long standing history of wound infection, which has required multiple re-operations for wound washout and change of poly.Surgery yesterday also resulted in exchange of humeral poly and also the glenosphere on this occasion, with copious lavage.Multiple tissue specimens taken.

• Brand Name: AEQUALIS REVERSED GLENOSPHERE CENTERED 42 MM X 29MM
• Type of Device: 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: 15529476
• MDR Text Key: 301036622
• Report Number: 3000931034-2022-00334
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386935916
• UDI-Public: 03700386935916
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K081059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/10/2023
• Device Model Number: DWD193
• Device Catalogue Number: DWD193
• Device Lot Number: 7077AT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male