MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CPCS COCR PRIM HO 12/14 SZ 4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 71312374

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/18/2019

Event Type  malfunction  

Event Description

It was reported that during surgery, while inserting the stem doctor noticed that device didn;t have any laser etching on lateral side of the stem.Surgeon used a marking pen to trace round marked side of the prosthesis and inserted stem to approximate position.No injury reported.

Manufacturer Narrative

Additional information received by the customer has identified that this event has been already reported under complaint (b)(4).The new information confirms that this is a duplicate complaint, therefore, if further details are provided in future confirming the opposite, our files will be updated accordingly and a further report will be submitted outlining both events details and our investigations performed.

• Brand Name: CPCS COCR PRIM HO 12/14 SZ 4
• 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: 9191893
• MDR Text Key: 162486695
• Report Number: 1020279-2019-03660
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010462176
• UDI-Public: 03596010462176
• 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: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71312374
• Device Lot Number: 15GM17244
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 10/15/2019
• Supplement Dates Manufacturer Received: 10/14/2019
• Supplement Dates FDA Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1