MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 2B 132.5DEG 70MM; SHOULDER JOINT METAL PROSTHESIS

Model Number	DWF602B
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	10/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision of reverse shoulder arthroplasty.The non-cemented humeral stem had migrated laterally since initial surgery.Revision surgery for removal confirmed it was loose and no bone ingrowth had occurred.There was a question of infection and the surgeon revised the patient with a washout of surgical site, implantation of new humeral stem with anti-biotic cement, replacement of glenosphere and treatment with intra and post-operative anti-biotics.
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
Additional Manufacturer Narrative
The reported event could be confirmed since evidences were provided and devices were returned for evaluation.The device inspection revealed that no bone ingrowth was noticed on the returned implants.But as the prosthesis implantation duration is unknown, no evaluation can be carried out further.Since pre-op x-rays were provided, the opinion of the medical expert was requested and stated as following: "the x-rays show the aequalis ascend flex stem has lateralized and tilted a little bit in varus as shown by the boundaries of the radiolucent lines.There is enough bone stock proximally.The first suspicion is on septic loosening (infection), as was suspected by the surgeon also during revision and was treated as such¿ (the most likely cause).Other factors could be also at the origin of the reported event as, an inadequate choice of the humeral stem ("undersizing of the humeral stem component") or a bone not sufficiently compacted ("hard to prove in this case").More detailed information about the complaint event (as immediate post-operative x-rays, patient data, implantation time) must be available to determine the exact root cause of the complaint event.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.If more information is provided, the case will be reassessed.
Event or Problem Description
Revision of reverse shoulder arthroplasty.The non-cemented humeral stem had migrated laterally since initial surgery.Revision surgery for removal confirmed it was loose and no bone ingrowth had occurred.There was a question of infection and the surgeon revised the patient with a washout of surgical site, implantation of new humeral stem with anti-biotic cement, replacement of glenosphere and treatment with intra and post-operative anti-biotics.

• Brand Name: TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 2B 132.5DEG 70MM
• Common Device Name: SHOULDER JOINT METAL PROSTHESIS
• 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: 12859586
• Report Number: 3000931034-2021-00342
• Device Sequence Number: 19985753
• Product Code: KWS
• UDI-Device Identifier: 03700386944512
• UDI-Public: 03700386944512
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/19/2023
• Device Model Number: DWF602B
• Device Catalogue Number: DWF602B
• Device Lot Number: 0110AU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 03/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2018
• 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 Sex: Male