MAUDE Adverse Event Report: TORNIER INC PERFORM REVERSED LATERALIZED GLENOSPHERE +3 DIA 36MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	DWJ022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	08/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
# ae - unk (b)(6) 2021 (date of visit) (b)(6) 2021- post-op complication: patient complaining of increased pain; x-rays reveal acromial fracture (not present pre-op); noticed as not related to the study device; possible relatedness to the surgical procedure.Conservative care.This ae is currently unresolved.(primary study surgery : (b)(6) 2021 : reversed configuration - stem aeq ascend flex 3a standard ptc humeral stem; tray low offset +0mm; insert standard 36 dia + 6mm/ 12.5b; glenoid baseplate perform reversed standard baseplate 25mm; central fixation 6,5mm; glenoid lateralized +3mm dia 36mm).
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device not explanted.
Event or Problem Description
# ae - (b)(6) 2021 (date of visit) (b)(6) 2021- post-op complication : patient complaining of increased pain; x-rays reveal acromial fracture (not present pre-op); noticed as not related to the study device; possible relatedness to the surgical procedure.Conservative care.This ae is currently unresolved.(primary study surgery : (b)(6) 2021 : reversed configuration - stem aeq ascend flex 3a standard ptc humeral stem; tray low offset +0mm; insert standard 36 dia + 6mm/ 12.5b; glenoid baseplate perform reversed standard baseplate 25mm; central fixation 6,5mm; glenoid lateralized +3mm dia 36mm).
Additional Manufacturer Narrative
Please note correction to g1 the reporting entity and reporting contact.The reported event could be confirmed.X-rays were returned for evaluation and confirmed the event noted in this complaint.The device inspection was not possible as the product was not returned for investigation.The batch record could not be reviewed because the affected device was not returned, and the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.The medical opinion of a medical expert was requested to evaluate the risk of this event: after review of the tornier shout clinical report and provided x-rays - synopsis of this case: 76-year-old, female, low bmi (20) and reversed shoulder implant in the right dominant side.The x-rays show a well implanted rtsa with no signs of loosening, malposition and/or infection.The x-rays also show an acromion fracture.Conclusion: stress-fracture of the right acromion in a patient with three risk factors for that in rtsa: age, sex and dominant side.There are no apparent other factors as far as the information provides.There are no indications that indict the surgical technique as an apparent cause of this adverse event.More information as well as the affected device must be available in order to determine the exact root cause of the alleged failure.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: PERFORM REVERSED LATERALIZED GLENOSPHERE +3 DIA 36MM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12763214
• Report Number: 3004983210-2021-00079
• Device Sequence Number: 11800246
• Product Code: PHX
• UDI-Device Identifier: 00846832061938
• UDI-Public: 00846832061938
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K161742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: DWJ022
• Device Catalogue Number: DWJ022
• 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: 10/12/2021
• Supplement Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 02/09/2022
• 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: Other
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 54 KG