MAUDE Adverse Event Report: TORNIER S.A.S AEQUALIS REVERSED; PROSTHESIS SHOULDER POLYMER / METAL

Model Number	HUMERAL SPACER 36MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/18/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) 2016: rsa for rotator cuff tear.(b)(6) 2017: suspicion of an infection.(b)(6) 2017: suspicion of suppurative arthritis.All the implants were removed and the surgeon performed debridement and filled the site with a cement containing antibiotics.As the patient has had an infection before, they had done thorough tests and administered medicines to the patient prior to the operation.They think that the patient was a carrier of infection and got the infection.No devices will be returned.
Additional Manufacturer Narrative
On november 10st, 2020 stryker trauma and extremities acquired tornier (b)(4).An effort was made to align the acquired entity complaint files with stryker's policies and procedures.Stryker has performed retrospective review of complaints and the reportability decision was revised to report this incident under the mdr process.Additional devices listed in this report: cat: dwb991; aequalis reversed adaptor ø36 mm; serial # (b)(4).Cat: dwd054; aequalis reversed adaptor metaphysis union screw; serial # (b)(4).Cat: dwe050; aequalis reversed cementless humeral stem 12x100mm, hap coated; serial # (b)(4) (same patient refer to mdr# 3000931034-2021-00067).Cat: dwe001; aequalis reversed 36mm cementless metaphysis; serial # (b)(4) (same patient refer to mdr# 3000931034-2021-00067).Cat: dwb251; aequalis humeral head 50x19; serial # (b)(4).A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.A review of the device history for the reported lot did not indicate any abnormalities.Infection can be related to several reasons: a previous surgery, a sub-acromial dead space, a poor sterile technique, more fragile patients or younger male patients who have a greater risk.After checking the sterile md release sheets of the complaint parts, no issue has been reported.All concerned results were compliant.No other complaint has been reported since today regarding infections with parts of the same lots implanted and regarding the traceability history of the lots.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• Brand Name: AEQUALIS REVERSED
• Common Device Name: PROSTHESIS SHOULDER POLYMER / METAL
• Manufacturer (Section D): TORNIER S.A.S; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• Manufacturer Contact: laurent ray ; 161 rue lavoisier; montbonnot saint martin 38330 ; FR 38330
• MDR Report Key: 13607005
• Report Number: 3000931034-2022-00070
• Device Sequence Number: 14939278
• Product Code: KWS
• UDI-Device Identifier: 03700386916120
• UDI-Public: 03700386916120
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K030941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2017

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 Expiration Date: 07/25/2019
• Device Model Number: HUMERAL SPACER 36MM
• Device Catalogue Number: DWB931
• Device Lot Number: 4401AO
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2017
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2014
• 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: Male
• Patient Weight: 51 KG