MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 36 S/+0; PROSTHSS,HIP,SMI-CNSTRND,METAL/CERAMIC/PLYMR,CEMENTED OR NON-POROUS,UNCEMENTED

Model Number 75100856

Device Problem Scratched Material (3020)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/08/2020

Event Type  malfunction  

Event Description

It was reported that during surgery, liner (71332754) was implanted and when trial head (75100856) was done being used to make surgical assessment of length and offset, scratches were noticed on liner.Since no backup device was available, a liner with different size was used to complete the procedure (71339554).Once the stem and head (71343200) were implanted, as surgeon was trying to remove the head, stem and head were removed as one piece and scratches were noticed on the oxinium head.Procedure was completed with a backup device of the same size for the head.A delay of less than 1 hour was reported.

Manufacturer Narrative

It was reported that during surgery, the liner was implanted and when the trial femoral head (b)(6) was done being used to make surgical assessment of length and offset, scratches were noticed on the liner.The device, intended for use in treatment, was not sent back for investigation nor was a batch number communicated.An appropriate investigation of the device could therefore not be conducted.Based on available information the stated failure mode cannot be confirmed and the root cause stays undetermined.The need for corrective action is not indicated.The complaint will be reopened should additional information or the device in scope be received.Smith and nephew will continue to monitor this device for similar issues.

Manufacturer Narrative

It was reported that during surgery, the liner was implanted and when the trial femoral head (75100856) was done being used to make surgical assessment of length and offset, scratches were noticed on the liner.The device, intended for use in treatment, was sent back for investigation.Upon visual inspection the trial head was confirmed to show only minor scratches from use.Apart from that no damage could be observed.The complaint history review revealed no additional complaints for the batch in question.A review of the batch record revealed no deviations from the standard manufacturing process.There is no indication that the device failed to match specification at the time of manufacturing.Based on the conducted investigation the root cause is attributed to wear and tear of the device.The need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor this device for similar issues.The received device will be discarded.

• Brand Name: TRIAL FEMORAL HEAD 36 S/+0
• Type of Device: PROSTHSS,HIP,SMI-CNSTRND,METAL/CERAMIC/PLYMR,CEMENTED OR NON-POROUS,UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; baar 06340 ; SZ 06340
• MDR Report Key: 10022485
• MDR Text Key: 189870930
• Report Number: 1020279-2020-01442
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07611996121896
• UDI-Public: 07611996121896
• Combination Product (y/n): N
• PMA/PMN Number: K132435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 75100856
• Device Catalogue Number: 75100856
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1