MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TNDM BP SHL/XLPE LNR 51OD 26ID; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71325051

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

Patient Problem Joint Dislocation (2374)

Event Date 08/19/2020

Event Type  Injury  

Event Description

It was reported that during procedure, after implantation it was discovered that patient suffered from a dislocation.Head was exchanged but when the surgeon could not remove it without explanting the stem.Other implants which were prepared but other size were implanted.

Manufacturer Narrative

D10: concomitant part added case (b)(4).D1: brand name updated.D4: catalog number, lot number, expiration date and unique identifier (udi) # updated.H4: manufacture date updated.

Manufacturer Narrative

H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device has signs of damage from implantation / extraction.The head was returned still connected to a stem and could not be removed.The head was also still assembled inside a bipolar shell.The clinical/medical evaluation concluded that it was reported that during procedure, after implantation it was discovered that patient suffered from a dislocation.Head was exchanged but when the surgeon could not remove it without explanting the stem.Other implants which were prepared but other size were implanted.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.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: TNDM BP SHL/XLPE LNR 51OD 26ID
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 10538503
• MDR Text Key: 207103029
• Report Number: 9613369-2020-00179
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71325051
• Device Lot Number: 19AM24280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Date Manufacturer Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 75002701 SL-PLUS STANDARD STEM 4 NON-CEMENTED.; UNKNOWN FEMORAL HEAD MEMPHIS OX.
• Patient Outcome(s): Hospitalization; Required Intervention