MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 2B 132.5DG 70MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWF602B
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Subluxation (4525); Joint Laxity (4526); Implant Pain (4561)
Date of Event	11/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.H3 other text : device disposition is unknown.
Event or Problem Description
The patient experienced shoulder instability with subluxations.These episodes occurred when holding a coat close to the body and reaching across the body without any weight, with the shoulder sliding forward and then quickly returning to its place.Two additional subluxation incidents were noted on a different date.The patient received non-operative care, specifically physical therapy.Upon physician assessment, there were no signs of various shoulder issues on imaging at the two-year visit.
Additional Manufacturer Narrative
Please note the corrections made to the device code and clinical signs code: the reported event was not confirmed since the device was not returned for evaluation and no other evidences were provided.The opinion of the medical expert was requested on this case despite the limited information provided and stated as following: "reading the subject information, i can confirm that the patient had a stress fracture of the acromion, and that this ae was resolved by rest and prp injection into the deltoid muscle.It is an ae that can be linked to the procedure, it is a well-known ae in reverse total shoulder arthroplasty.It is not linked especially to either the humeral or glenoid device as such.In all cases of reverse total shoulder arthroplasty more stress is applied on the acromion as compared to anatomic total shoulder arthroplasty, and this may lead to stress fractures of the acromion/scapular spine".More detailed information about the complaint event as well as the affected device must be available in order to clearly determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
A patient presented with shoulder pain exacerbated by lying on the left side.Initial x-rays were inconclusive but indicated a suspected stress reaction due to deltoid tension.A bone scan on a later date, confirmed an acromial stress reaction.Treatment involved six weeks of sling use followed by physical therapy (pt), which did not alleviate symptoms.Another bone scan on the same day confirmed an acromial stress fracture.Pt continued, supplemented by a platelet-rich plasma (prp) injection to the deltoid.The adverse event resolved without further issues.

• Brand Name: TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 2B 132.5DG 70MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18096919
• Report Number: 3000931034-2023-00415
• Device Sequence Number: 5671744
• Product Code: KWS
• UDI-Device Identifier: 03700434020748
• UDI-Public: 03700434020748
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2024

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 Catalogue Number: DWF602B
• 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: 10/12/2023
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 03/04/2024
• 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: Male
• Patient Weight: 110 KG