MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED II DIA29 L30 THREADED POST BASE PLATE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWE830
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	04/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a shoulder replacement surgery.Post-op the patient reports having severe pain.Patient id: (b)(6).
Additional Manufacturer Narrative
The device will not be returned as it remains implanted.If additional information becomes available, it will be provided in a supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed since the involved devices were not returned for evaluation and no additional information will be provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.Since this event is a multidimensional issue (orthopadics combined with oncology), the opinion of a medical expert was sought: "please note the time-span between implantation of the device and the detected breast cancer: this is about 15months (that¿s too short of a period for a detectable breast cancer to develop".Question: could the prothesis have caused the cancer ? answer: "no this is not possible given the short period of time between implantation and the presentation of detectable breast cancer".Question: could the cancer have caused the pain that the patient experienced before the prosthesis implantation ? is a test (to detect any cancer) performed before the prosthesis implantation ? answer: "theoretically this is possible, but hard to say without the clinical information to access that (history of shoulder pain, location of pain, physical examination) and the lack of imaging modalities (x-ray, ct-scan, or mri).Usually, these clinical and image-based evaluations rule out a non-joint related source of pain".Following to additional information provided by the medical center, the opinion of the medical expert was sought and stated as following: question: do you see here any new factor(s) that could have contributed to the reported event ? answer: "there¿s no relationship between the right shoulder prosthesis and the diagnosis of breast cancer.The surgical intervention in the right side (.) had to be surgically addressed to treat the patient¿s breast cancer.There are no new factors to be linked to this adverse event".Based on the provided information above, it is unlikely that the prosthesis could have caused the reported breast cancer.As for the root cause the reported pre-operatively pain, more information is required in order to determine the factors.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.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the patient underwent a shoulder replacement surgery.Post-op the patient reports having severe pain.Patient id: (b)(6).

• Brand Name: AEQUALIS REVERSED II DIA29 L30 THREADED POST BASE PLATE
• 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): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13651232
• Report Number: 3000931034-2022-00134
• Device Sequence Number: 14083266
• Product Code: KWS
• UDI-Device Identifier: 03700386952739
• UDI-Public: 03700386952739
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K132285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: DWE830
• Device Catalogue Number: DWE830
• 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: 02/04/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 08/04/2022
• 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: 82 YR
• Patient Sex: Female