MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HEAD 22 + 0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 71302200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 07/28/2020

Event Type  Injury  

Event Description

It was reported that at some point in the last 3 months, this patient had a fall onto their thr, which resulted in the constrained r3 liner locking ring breaking, therefore leading to instability and damage to the liner.The revision surgery was performed and the liner and head were explanted.

Manufacturer Narrative

It was reported that the patient had a fall onto their thr, which resulted in the constrained r3 liner locking ring breaking, therefore leading to instability and damage to the liner.Revision surgery performed; liner and head explanted.The affected cobalt chrome femoral head, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.However picture was provided which showed the broken components.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.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 and the instructions for use found that the reported failure was documented appropriately.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.The cause of the reported event was stated as a patient fall.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: COCR 12/14 FEM HEAD 22 + 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: 10444580
• MDR Text Key: 204084969
• Report Number: 1020279-2020-04159
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 03596010194039
• UDI-Public: 03596010194039
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/09/2020

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 Model Number: 71302200
• Device Catalogue Number: 71302200
• Device Lot Number: 17GM15173A
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/24/2020
• Supplement Dates Manufacturer Received: 10/23/2020
• Supplement Dates FDA Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention