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

Model Number	DWD067
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Extraskeletal ossification (1428)
Date of Event	05/26/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
"it was reported that a patient had an heterotopic ossification of the glenoid.Patient id: (b)(6)".
Additional Manufacturer Narrative
On november 10th, 2020 stryker trauma and extremities acquired tornier (b)(4).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.Per definition, a heterotopic ossification is the presence of bone in soft tissue where bone normally does not exist which lead to small bone nodules in excess, serious pains.General reasons are not well known but the most often they follow after injuries to the spinal cord injuries, neurologic troubles, traumatisms, amputations, surgeries.Factors inherent to reversed shoulder arthroplasty reported to increase the risk of heterotopic ossification include surgical approach and the extent of operative release of soft tissues.Size of the glenosphere does not seem to be a significant factor.The diagnosis has also been described as a possible risk factor (higher incidence with cuff tear arthroplasty) than in other pathologies.

• 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: 13607115
• Report Number: 3000931034-2022-00086
• Device Sequence Number: 13942384
• Product Code: KWS
• UDI-Device Identifier: 03700386928239
• UDI-Public: 03700386928239
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K061439
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2018

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: 11/25/2020
• Device Model Number: DWD067
• Device Catalogue Number: DWD067
• Device Lot Number: AA1236
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2015
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 118 KG