MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HEAD 26 + 0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 71302600

Device Problem Unintended Movement (3026)

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Date 09/11/2020

Event Type  Injury  

Event Description

It was reported the first revision tka surgery was on (b)(6) 2018.Patient suffered dislocation of femoral head and retainer ring from acetabular shell and constrained liner construct.Primary surgery date unknown.Second revision (b)(6) 2020.No injury reported except need for revision.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that the root cause of the first episode of dislocations cannot be concluded.The length of time insitu with normal ware may have contributed to the issue.The stated poor gluteal musculature and the reported ¿traumatic event of a forward flexion and the popping of the device¿ may have contributed to the cause of the second episode dislocations.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 have no 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.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or 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: COCR 12/14 FEM HEAD 26 + 0
• 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: 10653064
• MDR Text Key: 210583235
• Report Number: 1020279-2020-05282
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 03596010194077
• UDI-Public: 03596010194077
• Combination Product (y/n): N
• PMA/PMN Number: K963509
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

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 Model Number: 71302600
• Device Catalogue Number: 71302600
• Device Lot Number: 17AM22744
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 10/08/2020
• Supplement Dates Manufacturer Received: 06/26/2021
• Supplement Dates FDA Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 86 YR