MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CPCS COCR PRIM HO 12/14 SZ 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 71312371

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Injury (2348)

Event Date 01/31/2020

Event Type  Injury  

Event Description

It was reported that the original thr was performed at (b)(6) on (b)(6) 2015.Revision surgery was performed on (b)(6) 2020 due to loosening.The stem was explanted.

Manufacturer Narrative

It was reported that after five years of implantation a revision surgery was performed due to loosening.The affected cobalt chrome femoral head and cpcs cobalt chrome stem, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts 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 products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the adverse event could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.This reported failure has been identified in the instructions for use and risk management files as potential adverse events.Some potential causes of loosening could include but not limited to traumatic injury, fit/sizing, abnormal motion over time, poor bone ingrowth or osteolysis.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 the devices or additional information be received, the complaint will be reopened.

• Brand Name: CPCS COCR PRIM HO 12/14 SZ 1
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9699347
• MDR Text Key: 178750506
• Report Number: 1020279-2020-00517
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010462145
• UDI-Public: 03596010462145
• Combination Product (y/n): N
• PMA/PMN Number: K823727
• 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: 05/11/2020

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 Expiration Date: 06/21/2018
• Device Model Number: 71312371
• Device Catalogue Number: 71312371
• Device Lot Number: 08FM16749
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 02/12/2020
• Supplement Dates Manufacturer Received: 02/03/2020
• Supplement Dates FDA Received: 05/11/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention