MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG BIPOLAR PROSTHESIS 43/28; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number 75004360

Device Problem Insufficient Information (3190)

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

Event Date 02/26/2020

Event Type  malfunction  

Event Description

It was reported that during a hemi-hip replacement using a bipolar prosthesis.The poly liner was brought out during the removal of the retaining ring, which made the bipolar prosthesis unusable.A smaller size prosthesis was used to complete the surgery.No delay was reported and no extra cuts were performed due to downsizing the prosthesis.

Manufacturer Narrative

It was reported that during a hemi-hip replacement using a bipolar prosthesis the pe-liner was brought out during the removal of the retaining ring, which made the bipolar prosthesis unusable.The prosthesis, which intended use is in treatment, including the liner was sent back for investigation.No signs of wear and tear can be seen.The poly liner is not fixed in the cup anymore.Nevertheless, the retaining ring including the pe-inlay can easily be removed from the shell.However, the two components are sticking together.The parts were purchased and manufactured in 2018.In the corresponding batch record no deviation was found which could explain the occurred failure of the device.The risk of detachment of the liner from the shell is named in our corresponding risk management file and considered to be low.No other relating complaint was reported for this device.After communicating with the manufacturer of this device, the issue of a sticking together of pe components is known and always was relating to an improper sterilization using an autoclave.In the ifu for hip implants 12.23 (ed.05/16) it is described that the procedure should be done according to the corresponding surgical technique, furthermore no damaged components/implants should be used.It is described that implants provided as sterile must not be resterilised by the purchaser.Nevertheless, for this case the performed handling in the hospital is unknown and therefore it can not be concluded why this failure happened and the root cause remains undetermined.S+n will monitor this device for similar issues.The device was discarded.

• Brand Name: BIPOLAR PROSTHESIS 43/28
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 06340 ; SZ 06340
• MDR Report Key: 9891974
• MDR Text Key: 187023610
• Report Number: 9613369-2020-00074
• Device Sequence Number: 1
• Product Code: KWY
• 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: 06/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 75004360
• Device Lot Number: B1804388
• Date Manufacturer Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR