MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED BASEPLATE; SHOULDER JOINT METAL PROSTHESIS

Model Number	DIA29 X25 THREADED POST
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Pain (1994); Loss of Range of Motion (2032)
Date of Event	02/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient complains of everyday shoulder pain.He has significant pain, lack of motion, and weakness.Patient was put in a nursing home after surgery where little focus was on shoulder range of motion and strengthening.X-rays show no signs of fractures or loosening of implants.Patient wants to have his knee taken care of first before she considers surgical intervention on their shoulder.Patient id : (b)(6).
Additional Manufacturer Narrative
On november 10th, 2020 stryker trauma and extremities acquired tornier sas.An effort was made to align the acquired entity complaint files with stryker's policies and procedures.Stryker has performed retrospective review of complaints and the reportability decision was revised to report this incident under the mdr process.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Post-operative pain is described into literature as a common complication after shoulder replacement surgery.Pain can be related to several known reasons: infection.Implant material sensitivity.Inadequate choice of the implant components.Improper positioning of the implant components.- post-operative traumatic event.Reeducation procedure not respected or inadequate patient use in post-op (surgeon advices not respected).The long patient medical history could be at the origin of the persistent pain, stiffness and weakness.Based on the information available, root cause cannot be clearly determined.

• Brand Name: AEQUALIS REVERSED BASEPLATE
• Common Device Name: SHOULDER JOINT METAL PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• Manufacturer Contact: janice mithouard ; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• MDR Report Key: 13607038
• Report Number: 3000931034-2022-00094
• Device Sequence Number: 16636424
• Product Code: KWS
• UDI-Device Identifier: 03700386952722
• UDI-Public: 03700386952722
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K132285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2018

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: 09/01/2020
• Device Model Number: DIA29 X25 THREADED POST
• Device Catalogue Number: DWE825
• Device Lot Number: AA0217
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2018
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• 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: 79 YR
• Patient Sex: Female
• Patient Weight: 75 KG