MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN ORTHOPAEDIC RECONSTRUCTION DEV; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2020

Event Type  Injury  

Event Description

It was reported that during surgery the surgeon was trying to remove an sts stem with a broken trunion.The surgeon wanted to get more power so he attached a zimmer extraction device to the inserter to see if he could get more power to know the stem out.After about 3 or 4 hits with the zimmer device attached the tip of the inserter broke off into the stem internal to patient.The stem was then removed using an eto (all pieces recovered).It is unknown if there was a delay.There was a backup device available but not from s&n.

Manufacturer Narrative

The device, used in treatment was not returned for evaluation.Without the actual product, product evaluation could not be performed and complaint could not be confirmed.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of complaint history for the listed part revealed no prior complaints.According to clinical/medical investigation, the complaint reports while trying to remove an sts stem (by biomet) with a broken trunnion ,the surgeon wanted to get more power so he attached a zimmer extraction device to the inserter to see if he could get more power to know the stem out.After about 3 or 4 hits with the zimmer device attached the tip of the inserter broke off into the stem.The stem was removed using an eto (all pieces recovered).One x-ray was submitted for review.Smith and nephew has not received the device/adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.The impact to the patient cannot be determined with the available information.In conclusion, based on the information available the root cause of the inserter tip breaking, could have been the excessive force from the zimmer extraction device.The broken trunnion was not a smith and nephew component.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction or loss of sterility.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.We consider this investigation closed.Credit will not be issued for the device.

• Brand Name: UNKNOWN ORTHOPAEDIC RECONSTRUCTION DEV
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10073253
• MDR Text Key: 191527146
• Report Number: 1020279-2020-01795
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention