MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS REVINSERT 42MM 9TH C 7.5DG; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWF425C
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/13/2023
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 unknown.
Event or Problem Description
The patient experienced another shoulder dislocation while still recovering from surgery intended to address a previous dislocation.Following the recent dislocation, the patient remained in a sling for a week or two.In response, medical intervention involved locating the rotator cuff muscle and repositioning it in an attempt to address the underlying cause of the dislocation.Notably, the previously inserted stem was not removed during this procedure.
Additional Manufacturer Narrative
Corrections: d4 catalog #, d4 lot/serial no., d1 product long description.The reported event was not confirmed since no other evidence was provided regarding the second shoulder dislocation (no images provided).A device inspection was not possible since the affected device was not returned for evaluation.An x-rays inspection done by the medical expert from the provided x-rays (taken after the surgery of the second dislocation) revealed the following: images ¿show absence of the greater tuberosity and (¿) the absence of the lesser tuberosity in the correct place¿ (¿it is not likely the either greater or lesser tuberosity were anatomically reduced two months earlier), ¿the tray pointing left from the axis of the stem which is suggestive for retroversion¿, on the provided x-rays ¿only the third dislocation was apparent¿.Since data were provided, the opinion of a medical expert was sought and stated as following: "(.) after the revision surgery for the periprosthetic fracture, the right shoulder x-rays showed absence of the proximal humeral tuberosities, hence lack of attachment of an adequate soft tissue envelope to provide optimal support to joint stability (patient-related).In addition to that there may have been some excessive retroversion of the revive stem¿s proximal body (surgeon-related).(.) all-in-all a revision case because of a periprosthetic fracture, that have led to a situation of grossly disturbed anatomy due to patient-related factors and in addition to that possibly some excessive retroversion of the revision stem-construct (surgeon reported, although not quantified).In the images provided the implants are intact".A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed mainly to a patient-related issue.The instability followed the revision surgery for a postoperative traumatic periprosthetic humeral fracture which highly disturbed the patient¿s right shoulder anatomy (lack of soft tissues around the proximal part of the humerus and rotator cuff soft tissue reconstruction time).If the devices are returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The patient experienced another shoulder dislocation while still recovering from surgery intended to address a previous dislocation.Following the recent dislocation, the patient remained in a sling for a week or two.In response, medical intervention involved locating the rotator cuff muscle and repositioning it in an attempt to address the underlying cause of the dislocation.Notably, the previously inserted stem was not removed during this procedure.

• Brand Name: TORNIER FLEX SHOULDER SYS REVINSERT 42MM 9TH C 7.5DG
• 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: 19005250
• Report Number: 3000931034-2024-00168
• Device Sequence Number: 18501209
• Product Code: KWS
• UDI-Device Identifier: 03700434022445
• UDI-Public: 03700434022445
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2024

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: DWF425C
• Device Lot Number: 5891AY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2022
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 84 KG