MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE HA CTD ACET SHELL 48MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71331948

Device Problem Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to instability post fall and cup, liner and femoral head were removed.No other medical information is available.

Manufacturer Narrative

It was reported that a revision surgery was performed due to instability post fall and cup, liner and femoral head were removed.The associated oxinium femoral head, r3 acetabular liner and r3 3hole acetabular shell were returned and evaluated.A lab analysis conducted during this investigation indicated that scratches were visible on the rim of the acetabular cup as well as a few on the inside where the liner seats.A significant amount of bone on-growth was present on the outer porous region of the implant, indicating that the cup was well fixed into the acetabulum of the patient.Scratches that broke the oxide layer were present on the articulating surface and around the female taper of the femoral head.Scratches were visible on the liner¿s articulating surface, and scratches and gouging on the rim.Discoloration was visible on the od surface of the liner, as well as significant damage to the rotational tabs and the locking ring.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.No further investigation warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: R3 3 HOLE HA CTD ACET SHELL 48MM
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8845236
• MDR Text Key: 152761039
• Report Number: 1020279-2019-02875
• 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
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2022
• Device Catalogue Number: 71331948
• Device Lot Number: 12DM14704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Date Manufacturer Received: 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention