MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TNDM BP SHL/XLPE LNR 42OD 26ID; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71325042

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 05/14/2020

Event Type  Injury  

Event Description

It was reported that after a bha surgery with accord cable, performed on may 1st, during rehabilitation on may 14th, it was noticed a squeaking/noise coming out from the patient's hip.After a chest x-ray, the patient suffered a dislocation, and the patient had to undergo a revision surgery to correct the issue.The patient had the following devices implanted: tandem bipolar shell/xlpe liner 42mm od 26mm id, universal femoral head {} cocr 26mm -5ext, syn sel ii cem so 10/12 sz11, invis distal centralizer size 8mm, and buck femoral cement restrictor 18.5mm; but still it is unknown which device was explanted.

Manufacturer Narrative

H3, h6: it was reported that during rehabilitation, it was noticed a squeaking/noise coming out from the patient's hip.After a chest x-ray examination, it was noticed that the femoral head dislocated from the tandem component.The patient had to undergo a revision surgery to correct the issue.The femoral head and the liner along with the ring, used in treatment, were returned and evaluated.A visual inspection of the returned devices indicated minor signs of damage, except for the ring.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A dimensional evaluation was performed on the returned devices and noted that all features are within allowable tolerance per specifications.Only the locking ring is measured out of tolerance.Due to the material type (poly) and shape, it is typical to deform this component during disassembly.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.A medical analysis via x-ray indicated that the femoral head dislocated from the tandem component.Based on the provided pre-op imaging, there appears to be a displaced intertrochanteric and lesser trochanteric fracture of the right femur.The undated/unidentified post-op imaging shows the right tha and hook plate with 5 femoral cables.It was further communicated that it was not reported if the surgeon faulted any of the devices and ¿there is possibility of error¿.No further medical documentation was provided for inclusion in the medical investigation.Dislocation is a known potential complication in the early post-operative period and has been linked to poor adherence to post-operative hip precautions, trauma, insufficient proximal trochanteric/femoral support, and mal-positioning among other factors.The patient impact beyond the reported squeaking, dislocation and subsequent revision could not be determined as the patient outcome was reportedly ¿unknown¿.No further medical assessment can be rendered at this time.Based on this investigation, the need for corrective action is not indicated.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, the complaint will be reopened.(b)(4).

• Brand Name: TNDM BP SHL/XLPE LNR 42OD 26ID
• 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: 10143538
• MDR Text Key: 194809504
• Report Number: 1020279-2020-02323
• 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: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71325042
• Device Lot Number: 18LM13709A
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/14/2020
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention