UNKNOWN AEQUALIS REVERSED II HUMERAL IMPLANT
Received Jul 3, 2026 · Event occurred Jul 1, 2020
Report 3000931034-2026-00554 · MDR key 25701404
Device
Generic name
Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Manufacturer
Tornier S.a.s.Catalog number
UNK_WTM
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Pneumonia
- Pneumothorax
Narrative
Description of Event or Problem
THE MANUFACTURER RECEIVED STRYKER COLLABORATIVE STUDY (SCS) NAMED "A RETROSPECTIVE DATA COLLECTION OF THE TREATMENT OF SHOULDER JOINT REPLACEMENT WITH THE AEQUALISTM REVERSED II SHOULDER SYSTEM" THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF AEQUALIS REVERSED II SHOULDER SYSTEM. THE PATIENTS ANALYZED IN THIS REPORT WERE OPERATED BETWEEN (B)(6) 2011 AND (B)(6) 2020, AND OUTCOME PARAMETERS AT 2 AND 5 YEARS ARE CONSIDERED. DURING THE REVIEW OF THE REPORT, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, THE FOLLOWING ADVERSE EVENT WAS REPORTED: ONE PATIENT EXPERIENCED PULMONARY EVENT (PNEUMOTHORAX LEADING TO PNEUMONIA) WHICH REQUIRED DRAINAGE AND DRUGS. RELATED PROBABLY TO SURGICAL PROCEDURE.
Additional Manufacturer Narrative
THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE(S) WERE NOT RETURNED FOR EVALUATION, AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE CLINICAL SITE. MORE DETAILED INFORMATION ABOUT THE PATIENT'S MEDICAL HISTORY, THE EVENT DETAILS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.