Conventus Cage - PH, Medium PH-MRecalls & reported problems
Conventus Orthopaedics, Inc. · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814289020709), received between Jun 28, 2019 and Sep 20, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Slipped” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Slipped1
- Misassembly by Users1
Patient problems
- Fall1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 20, 2019Device Slipped
ON (B)(6) 2019, THE SURGEON IMPLANTED CONVENTUS PH CAGE IN THE LEFT ARM OF THE PATIENT. ON (B)(6) 2019, THE PATIENT FELL ON HER LEFT ARM. AROUND (B)(6) 2019 (THE EXACT DATE UNKNOWN), THE SURGEON IDENTIFIED THAT THE PH CAGE HAD SLIPPED INTO VARUS AND DECIDED TO REMOVE A SCREW APPLIED TO THE PH CAGE. ON (B)(6) 2019, THE SCREW WAS REMOVED. ON (B)(6) 2019, THE SURGEON IDENTIFIED THE PATIENT HAD AN INFECTION AT THE IMPLANT SITE AND DECIDED TO REMOVE THE PH CAGE IMPLANTED ON (B)(6) 2019. ON (B)(6) 2019, THE PH CAGE WAS REMOVED.
Patient problems: Fall; Unspecified Infection
MAUDE report 9101193 ↗MalfunctionJun 28, 2019Misassembly by Users; Misassembly by Users
IN (B)(6) 2016, THE PATIENT PRESENTED WITH A FAILED UNION OF A TWO-PART PROXIMAL HUMERUS FRACTURE FIXED WITH COMPETITIVE PROXIMAL HUMERUS PLATE (IMPLANT DEVICE NOT MANUFACTURED BY CONVENTUS). THE HUMERAL HEAD HAD COLLAPSED INTO VARUS. WHEN AND WHO INITIALLY PERFORMED THE IMPLANTATION OF THE COMPETITIVE PRODUCT ARE UNKNOWN. THE SURGEON REVISED THE FAILED FRACTURE WITH A CONVENTUS PH CAGE AND PLATE. ON (B)(6) 2017, DURING THE FOLLOW-UP APPOINTMENT, THE SURGEON NOTED THE HUMERAL HEAD WAS STARTING TO FALL BACK INTO VARUS AGAIN. THE PATIENT CHOSE TO LEAVE THE IMPLANT IN PLACE UNTIL (B)(6) 2019. ON (B)(6) 2019, A CONVENTUS EMPLOYEE WAS PRESENT DURING THE EXPLANT PROCEDURE, WHERE THE CONVENTUS CAGE IMPLANT WAS REMOVED. AFTER OVER TWO YEARS WITH A NON-UNION, THE IMPLANT WAS FOUND TO HAVE FAILED. AFTER REMOVAL, SOME SMALL METAL FRAGMENTS FROM THE CONVENTUS PH CAGE DEVICE WERE FOUND LEFT BEHIND IN THE POST-OP X-RAYS OF THE SHOULDER PROSTHESIS.
Patient problems: Pain
MAUDE report 8746455 ↗
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- TRIGEN 71676628Smith & Nephew, Inc. · NAIL, FIXATION, BONE1 recall0 reports
- NA 03.043.018Synthes GmbH · NAIL, FIXATION, BONE33 reports
- TRIGEN 71675383Smith & Nephew, Inc. · NAIL, FIXATION, BONE29 reports
- NA 03.010.441Synthes GmbH · NAIL, FIXATION, BONE27 reports
- NA 03.010.435Synthes GmbH · NAIL, FIXATION, BONE24 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.