MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE HA CTD ACET SHELL 60MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71331960

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 06/04/2020

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to dislocation.All the implants were removed, the femur was cabled, the acetabular cup was repositioned to the proper orientation and cemented in the stems (r3/cpcs with the accord cable).At the end of procedure joint stability was restored.

Manufacturer Narrative

Results of investigation: it was reported that a revision surgery was performed due to dislocation.The affected r3 acetabular shell, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part 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 product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found the event as a potential adverse event.A clinical analysis noted that reportedly, the cup was noted to be retroverted/not properly seated along with what appeared to be a small medial calcar fracture (suspected occurred during reduction) and small osteophytes around the cup.However, smith and nephew has not received the device and/or adequate documentation to fully evaluate the root cause of the reported event.Reportedly, suspected possible contributing factors to the reported dislocation were osteophytes and cup mal-positioning; the subsequent reduction was suspected of initiating the fracture and the events ultimately led to a revision.The patient impact beyond the reported events and revision could not be determined.No further medical assessment is warranted at this time.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, this complaint will be reopened and reevaluated.

• Brand Name: R3 3 HOLE HA CTD ACET SHELL 60MM
• 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: 10204189
• MDR Text Key: 196749616
• Report Number: 1020279-2020-02806
• 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: 09/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71331960
• Device Lot Number: 20AM10303
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/26/2020
• Supplement Dates Manufacturer Received: 09/03/2020
• Supplement Dates FDA Received: 09/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71332530 REF SPHER HEAD SCREW 30MM LOT# 18FM08797
• Patient Outcome(s): Hospitalization; Required Intervention