MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED II 36/42 COMBINATION INSERT; SHOULDER JOINT POLYMER PROSTHESIS

Model Number	DIAM 36MM LAT.+9 MM
Medical Device Problem Codes	Disassembly (1168); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	09/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the initial report submitted regarding this surgical event and medical device.
Event or Problem Description
"on (b)(6) 2015: surgery from tsa to rsa due to rct was done./ (b)(6) 2015: shoulder dislocation (no surgery, manual reduction) / (b)(6) 2015: insert and sphere were replaced due to instability.Latissimus dorsi transfer was done./ (b)(6) 2017: shoulder dislocation (b)(6) 2017: insert was replaced.The surgeon thinks that loosening of deltoid muscle has caused the shoulder dislocation.".
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS REVERSED II 36/42 COMBINATION INSERT
• Common Device Name: SHOULDER JOINT POLYMER PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• MDR Report Key: 7052186
• Report Number: 3000931034-2017-00187
• Device Sequence Number: 13726061
• Product Code: KWS
• UDI-Device Identifier: 03700386932748
• UDI-Public: 03700386932748
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2017

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: Physician
• Device Expiration Date: 03/31/2019
• Device Model Number: DIAM 36MM LAT.+9 MM
• Device Catalogue Number: DWD989
• Device Lot Number: 1477AO
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 11/22/2017
• Supplement Report FDA Received Date: 04/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Weight: 69