Arthrex® AR-9341-16Recalls & reported problems
Arthrex, Inc. · ARTHREX ECLIPSE HUMERAL HEAD, 41/16 · Class 2 · Implant
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867059986), received between Dec 4, 2019 and May 7, 2024 — classified as 5 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 reports).
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.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem3
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Insufficient Device Problem Information1
Patient problems
- Pain3
- Failure of Implant1
- No Code Available1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryMay 7, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT AFTER AN INITIAL SHOULDER PROSTHESIS SURGERY 2020 THE PATIENT NOW EXPERIENCED PAIN SINCE SEVERAL MONTHS. *** UPDATE DW 25-APR-2024: FURTHER INFORMATION WERE PROVIDED THAT NO SPECIFIC DEVICE MALFUNCTION WAS IDENTIFIED. THE PATIENT SUFFERS FROM PAINT AND NUMBNESS IN THE SIDE OF THE UPPER ARM. THE PATIENT FURTHER PROVIDED THE INFORMATION THAT THE INITIAL SURGERY WAS PERFORMED IN MÜNSTER BUT DID NOT PROVIDE THE NAME OF THE HOSPITAL WHERE SHE WAS TREATED. SHE FURTHER REPORTED THAT THE SHE FEELS THE PAIN SINCE HALF A YEAR AND DID NOT EXPERIENCE ANY ISSUES BEFORE.
Patient problems: Pain
MAUDE report 19258759 ↗InjuryOct 27, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT A REVISION SURGERY WAS NECESSARY DUE TO A WORN GLENOID. IT WAS FURTHER REPORTED THAT THE IMPLANT WAS IMPLANTED AROUND 10 YEARS AGO IN THE SCHULTHESS KLINIK. NO FURTHER INFORMATION PROVIDED.
Patient problems: Failure of Implant
MAUDE report 18021923 ↗InjuryJan 23, 2023Insufficient Device Problem Information; Patient Device Interaction Problem; Patient Device Interaction Problem
ON (B)(6) 2023, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A SEVERE COMPLICATION OCCURRED OF A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY. PATIENT UNDERWENT TOTAL SHOULDER PROCEDURE ON (B)(6) 2020, IN WHICH THE ARTHREX ECLIPSE IMPLANT SET WAS USED. A YEAR LATER, (B)(6) 2022, PATIENT PRESENTED PAIN AND CUFF DYSFUNCTION. A DECISION WAS MADE TO CONVERT THE ARTHROPLASTY PROCEDURE TO A REVERSE PROCEDURE ON (B)(6) 2022. THIS IS ALL THE INFORMATION PROVIDED AT THIS TIME. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023: DURING THE ORIGINAL SURGERY ON (B)(6) 2020, THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED: ARTHREX ECLIPSE HUMERAL HEAD SIZE 41X16MM, PART NUMBER AR-9341-16, LOT1911007. ARTHREX ECLIPSE CAGE SCREW MEDIUM, PART NUMBER AR-9301-02, LOT 18.01106. ARTHREX ECLIPSE TRUNION 39MM, PART NUMBER AR-9301-39CPC LOT 18.01134. ARTHREX UNIVERS VAULT LOCK GLENOID SMALL, PART NUMBER AR-9106-01, LOT 1027261912. DURING THE REVISION SURGERY, THE FOLLOWING ARTHREX PRODUCTS WERE EXPLANTED: ARTHREX UNIVERS VAULT LOCK GLENOID SMALL, PART NUMBER AR-9106-01, LOT 1027261912. ARTHREX ECLIPSE HUMERAL HEAD SIZE 41X16MM, PART NUMBER AR-9341-16, LO 1911007. ARTHREX ECLIPSE CAGE SCREW MEDIU
Patient problems: Pain
MAUDE report 16223485 ↗InjuryDec 16, 2019Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT (FEMALE, (B)(6) YEARS), HAD AN ECLIPSE TOTAL SHOULDER ON (B)(6) 2016. DUE TO A SUBSEQUENT TORN ROTATOR CUFF, SHE NEEDED TO HAVE A REVERSE TOTAL SHOULDER ON (B)(6) 2019. REPORTER STATED THAT THE TORN ROTATOR CUFF WAS NOT DUE TO PRODUCT MALFUNCTION. REMOVED FROM THE PATIENT WAS AR-9341-16, AR-9300-41CPC AND AR-9301-01.
Patient problems: No Code Available
MAUDE report 9473749 ↗InjuryDec 4, 2019Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT HAD AN ECLIPSE SURGERY ON THE (B)(6) 2016. FOR A WHILE EVERYTHING WAS FINE AND NO COMPLAINTS, BUT THEN ALL OF A SUDDEN SHE FELT PAIN. THE SURGEON DECIDED ON A REVISION SURGERY WHERE THE FOLLOWING ARTHREX DEVICES WERE EXPLANTED: AR-9105-01, AR-9341-16 (1295154707), AR-9300-41CPC (14.641), AR-9301-01 (13.225) A NEW PROSTHESIS FROM ANOTHER MANUFACTURER WAS IMPLANTED. NO FURTHER INFORMATION RECEIVED.
Patient problems: Pain
MAUDE report 9409926 ↗
Other Total shoulder arthroplasty system devices
- Arthrex® AR-9301-03Arthrex, Inc. · Total shoulder arthroplasty system12 reports
- Arthrex® AR-9301-01Arthrex, Inc. · Total shoulder arthroplasty system9 reports
- Arthrex® AR-9349-18Arthrex, Inc. · Total shoulder arthroplasty system9 reports
- Arthrex® AR-9347-18Arthrex, Inc. · Total shoulder arthroplasty system7 reports
- Arthrex® AR-9343-16Arthrex, Inc. · Total shoulder arthroplasty system7 reports
- Arthrex® AR-9301-02Arthrex, Inc. · Total shoulder arthroplasty system6 reports
- Arthrex® AR-9345-17Arthrex, Inc. · Total shoulder arthroplasty system6 reports
- Arthrex® AR-9301-47CPCArthrex, Inc. · Total shoulder arthroplasty system3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.