MAUDE Adverse Event Report: TORNIER INC AEQUALIS REVERSED STANDARD INSERT 36 MM X 9 MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWB994
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.H3 other text : device was discarded.
Event or Problem Description
It was reported that the patient underwent right reverse shoulder replacement, in 2017.Recently the patient had discharging sinus, over prosthetic joint.Surgeon decided to remove any loose prosthesis.Multiple serous and tissue specimens taken from right prosthetic shoulder joint.Humeral component, though very well fixed, was removed.Glenosphere removed - specimens taken of "jelly-like" material behind the glenosphere.Glenoid baseplate left insitu, as very well fixed.Copious lavage.Antibiotic laden cement spacer placed in joint space, and wound closed.The surgeon prescribed the patient 2 weeks of iv antibiotics.The patient will then undergo a 2nd stage revision.
Additional Manufacturer Narrative
The reported event could not be confirmed since the devices were not returned for evaluation and no other evidences were provided.Only a photo of the explanted parts taken during revision surgery was provided with no evidence for investigation.Since data were provided, the opinion of a medical expert was sought and stated as following: "with the information available it is not possible to confirm the event of infection 100% sure, without results from x-rays, tissue cultures, etc.We can be sure the surgeon explanted four parts of the rtsa, but we¿ll need more information to confirm the diagnosis and look in to factors that may have played a role".More detailed information about the complaint event as well as the affected devices must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lots 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 more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that the patient underwent right reverse shoulder replacement, in 2017.Recently the patient had discharging sinus, over prosthetic joint.Surgeon decided to remove any loose prosthesis.Multiple serous and tissue specimens taken from right prosthetic shoulder joint.Humeral component, though very well fixed, was removed.Glenosphere removed - specimens taken of "jelly-like" material behind the glenosphere.Glenoid baseplate left insitu, as very well fixed.Copious lavage.Antibiotic laden cement spacer placed in joint space, and wound closed.The surgeon prescribed the patient 2 weeks of iv antibiotics.The patient will then undergo a 2nd stage revision.

• Brand Name: AEQUALIS REVERSED STANDARD INSERT 36 MM X 9 MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16784881
• Report Number: 0001649390-2023-00066
• Device Sequence Number: 20256720
• Product Code: KWS
• UDI-Device Identifier: 03700386916557
• UDI-Public: 03700386916557
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K050316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2023

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 Expiration Date: 07/11/2022
• Device Model Number: DWB994
• Device Catalogue Number: DWB994
• Device Lot Number: AB2223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2017
• 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: 81 YR
• Patient Sex: Male
• Patient Weight: 80 KG