MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG PROMOS REVERSE BODY Ø42/10MM NON-CEM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number ED75003714

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 01/01/1901

Event Type  Injury  

Event Description

It was reported a promos reverse body screw breakage after 10 years of implantation without any clear reason.Reverse body was revised.

Manufacturer Narrative

Results of investigation:it was reported that a revision surgery took place 10 years after implantation due to implant breakage.The promos reverse gleosphere (75003709), reverse body (75003714) with pe-insert (75003705) and humeral stem (75006607) have been returned for investigation.However, the reverse glenoid baseplate (75003722) and the associated bone screws (5003698 / 75003701) were not returned.A visual inspection confirmed the reported breakage.The humeral stem broke at the taper connection.The end of the broken reverse body screw remains with the humeral stem.The fractured surface shows signs of mechanical intrusion, which was probably caused by constant friction against the reverse body after the breakage.The pe-insert shows signs of wear and delamination especially on the exterior area of the sphere.However, there are no signs of extensive pe wear that could be attributed to the stem taper breakage.No other damage was observed on the inspected parts that could have contributed to the reported implant breakage.A fracture analysis revealed that the breakage of the reverse body screw was caused by fatigue.Common features of a fracture surface could not be observed on the broken taper, due to the previously described mechanical damage after the implant breakage.The alloy compositions matched the specification.A medical investigation was conducted.The intraoperative report was submitted with the complaint documents.The reports did not suggest any reason or precipitating event or trauma that may have led to this breakage.X-rays were provided for review which shows decreased joint space, which could indicate poly wear, but in another image it does show the breakage at the humeral stem but no indication of the root cause based on the image provided.All documents and images provided as of this date have been reviewed and consider and unless noted do not contribute to the clinical investigation.The impact to the patient beyond the revision surgery was not provided in the reports.A review of the batch record revealed no deviations from the standard manufacturing process that could have contributed to the reported incident.The material certificate for the promos humeral stem is available and matches the specification.A review of the complaint history revealed no other complaints for the batch of the promos reverse body and the promos humeral stem.There is no indication that the device failed to match specification at the time of manufacturing.In conclusion, based on available information the root cause of the breakage cannot clearly be identified and stays undetermined.It can however not be excluded that fatigue or trauma caused or contributed to the reported breakage.The executed investigation does not indicate the need for corrective action.Nevertheless, smith & nephew will continue to monitor the promos system for similar issues.The complained devices will be retained.

• Brand Name: PROMOS REVERSE BODY Ø42/10MM NON-CEM
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; baar 06340 ; SZ 06340
• MDR Report Key: 8458356
• MDR Text Key: 140118471
• Report Number: 9613369-2019-00027
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• PMA/PMN Number: K081016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2015
• Device Model Number: ED75003714
• Device Catalogue Number: ED75003714
• Device Lot Number: B0805864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Date Manufacturer Received: 03/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 75003698, PROMOS GLEN.BONE SCREW, LOT: A0807756; 75003701, PROMOS GLEN.BONE SCREW, LOT: A0800968; 75003705, PROMOS REVERSE PE , LOT: A0711032; 75003709, PROMOS REV GLENOSPHERE, LOT: A0711142; 75003722, PROMOS REVERSE GLEN. LOT: B0809865; 75006607, PROMOS HUMERAL STEM, LOT: E0808300
• Patient Outcome(s): Hospitalization; Required Intervention