MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC TORNIER FLEX SHOULDER SYSTEM HEAD HI OFFSET 43MMX16MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWF143
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a total shoulder replacement.Patient developed a cuff tear and pain.Humeral head migrated superiorly.Shoulder revision surgery performed today and converted to a reverse.Stem left in situ.Glenoid component removed and replaced with a reverse component.
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 that there was a total shoulder replacement.Patient developed a cuff tear and pain.Humeral head migrated superiorly.Shoulder revision surgery performed today and converted to a reverse.Stem left in situ.Glenoid component removed and replaced with a reverse component.
Additional Manufacturer Narrative
Please note the correction made to the catalog # and the d1 product long description: the reported event was confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.The device history 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 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.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: TORNIER FLEX SHOULDER SYSTEM HEAD HI OFFSET 43MMX16MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16821041
• Report Number: 3010667733-2023-00218
• Device Sequence Number: 12430025
• Product Code: KWS
• UDI-Device Identifier: 03700434022704
• UDI-Public: 03700434022704
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2023

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
• Device Model Number: DWF143
• Device Catalogue Number: DWF143
• 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: 03/29/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 06/20/2023
• 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: 70 YR
• Patient Sex: Female