MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN SMITH+NEPHEW DEV; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Injury (2348)

Event Date 07/27/2020

Event Type  Injury  

Event Description

It was reported that the patient had a shoulder prosthesis in 2014 (posttraumatic necrosis of the humeral head).Now the patient requires a revision because the rotator cuff had a rupture.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Results of investigation: it was reported that the patient had a shoulder prosthesis in 2014 (posttraumatic necrosis of the humeral head).Now the patient requires a revision because the rotator cuff had a rupture.The revision surgery did not take place yet.No information regarding the part numbers and the batch numbers of the parts, used in treatment, is available.Therefore, the complaint history as well as the batch records could not be reviewed.Additionally, no clinically relevant materials were received, therefore, a thorough medical assessment was not possible.As the devices are still implanted, a product evaluation could not be conducted.The risk is covered in the risk management files.The ifu lit.No.12.25 ed.07/10 does not list a rupture of the rotor cuff as a common side effect, however insufficient range of motion and shoulder instability are listed.Based on the available information, the failure mode cannot be confirmed and the root cause stays undetermined after investigation.Should additional information become available, this complaint will be reassessed.To date, no further actions are deemed necessary.Smith and nephew will monitor the implanted system for further similar issues.

• Brand Name: UNKN SMITH+NEPHEW DEV
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 10428587
• MDR Text Key: 203631315
• Report Number: 9613369-2020-00158
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/10/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 08/19/2020
• Supplement Dates Manufacturer Received: 10/26/2020
• Supplement Dates FDA Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention