MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNIV COCR 10/12 TAPER FEM HD 26MM -5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 11909

Device Problem Unintended Movement (3026)

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 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 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; however, it is still unknown which devices were explanted.The patient outcome is also unknown.

Manufacturer Narrative

Additional information in: d9, h6 (health effect - impact code & component code).Results of investigation: 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.Internal reference number: (b)(4).

• Brand Name: UNIV COCR 10/12 TAPER FEM HD 26MM -5
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10148621
• MDR Text Key: 194975321
• Report Number: 1020279-2020-02363
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00885556008720
• UDI-Public: 885556008720
• Combination Product (y/n): N
• PMA/PMN Number: K072817
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

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: 11909
• Device Lot Number: 19MM05397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Initial Date Manufacturer Received: 05/14/2020
• Initial Date FDA Received: 06/12/2020
• Supplement Dates Manufacturer Received: 02/09/2021
• Supplement Dates FDA Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention