MAUDE Adverse Event Report: TORNIER INC AEQUALIS REVERSED MULTIDIR. SCREW D4.5 L 38 STERILE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWD138
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Hospital would not release.
Event or Problem Description
It was reported that the flex stem was revised for loosening due to infection.The patient was treated for infection.This potentially reduced the function as the stem moved into the varus.
Additional Manufacturer Narrative
Correction d4 (lot#).The reported event could be confirmed for the loosening but could not be confirmed for the infection since the device was not returned for evaluation and no other evidences were provided.Since x-ray was provided, the opinion of the medical expert was requested and stated as following: "the x-ray indeed shows a humeral implant that has migrated into varus.The outline of its index position (how it was positioned during the primary placement) is still visible.Such an event confirms loosening, but is doesn't necessarily indicate infection since this kind of information is not available at this moment, i cannot assess the reasons for this diagnosis of periprosthetic joint infection".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.However, based on the clinical opinion on the potential risk of infection caused by sterile packed stryker implants and instruments, ¿any kind of surgery bears the risk of infection.In trauma and orthopedic surgery with external or internal fixation implants or endoprostheses the infection risk varies between 0.5 % and 5 %, exceptionally up to 10 % and beyond, mainly depending on the respective surgical procedure and the typical patient population.¿ 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 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 flex stem was revised for loosening due to infection.The patient was treated for infection.This potentially reduced the function as the stem moved into the varus.

• Brand Name: AEQUALIS REVERSED MULTIDIR. SCREW D4.5 L 38 STERILE
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14112312
• Report Number: 3000931034-2022-00162
• Device Sequence Number: 16681367
• Product Code: KWS
• UDI-Device Identifier: 03700386917110
• UDI-Public: 03700386917110
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K050316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/01/2024
• Device Model Number: DWD138
• Device Catalogue Number: DWD138
• Device Lot Number: AC3444
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2022
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2019
• 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: Unknown