MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED GLENOSPHERE CENTERED 42 MM X 25MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWD183
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Osteolysis (2377); Metal Related Pathology (4530)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could not be confirmed since the devices were not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected devices were not returned and no other evidences were provided for investigation.Since this event is a particular issue, the opinion of the medical expert was requested with the limited information available and stated as following: ¿unfortunately, without access to any imaging it is not possible to assess this case¿; ¿since the nickel allergy is confirmed by the surgeon, it can be considered regarding this case.If the nickel allergy was known before the index-surgery, then the surgery was done despite the patient having a contraindication (known allergy to one of the materials).If the nickel allergy was not known before the surgery, then this metal allergy was not a known contraindication at the time of the index surgery.Sometimes long-term exposure may sensitize a patient to a material.It is common for debris particles/metal ions of one component reaching the opposing component as well since they do so via the articular space.It is remarkable however, that the glenoid side was unaffected by this".A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.A review of the labeling did not indicate any abnormalities."the humeral stem is manufactured from titanium alloy (tialv)", without nickel and "the glenoid sphere is made of chromium cobalt alloy (cocr)", with nickel.In this case, the root cause of the event is most probably due to patient conditions.But, more detailed information (as patient conditions, x-rays/images, clinical reports, batch numbers of the implants.) about the complaint event must be available in order to determine the exact root cause of the complaint event.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the patient may have an allergic reaction which caused loosening of the stem.The patient underwent a revision surgery.The patient was confirmed to have a nickel allergy.The only component with nickel is the glenosphere.
Event or Problem Description
It was reported that the patient may have an allergic reaction which caused loosening of the stem.The patient underwent a revision surgery.The patient was confirmed to have a nickel allergy.The only component with nickel is the glenosphere.
Additional Manufacturer Narrative
Correction: h1.

• Brand Name: AEQUALIS REVERSED GLENOSPHERE CENTERED 42 MM X 25MM
• 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: 17292990
• Report Number: 3000931034-2023-00206
• Device Sequence Number: 14981403
• Product Code: KWS
• UDI-Device Identifier: 03700386935855
• UDI-Public: 03700386935855
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K081059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2023

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 Model Number: DWD183
• Device Catalogue Number: DWD183
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 09/26/2023
• 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: 57 YR
• Patient Sex: Female