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

Model Number	71312374
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a thr was performed.Surgeon prepared acetabulum as per technique and inserted definitive components.Surgeon prepped femur for size 4ho cpcs cemented femoral stem.Femur prepped for cementing and 12mm centralizer applied to femoral stem and cement applied to femoral canal.As the surgeon was about to cement the femoral component into femur he noticed there wasn't any laser etching on the lateral side (surgeon facing) side of the stem.The surgeon could not visualize where the stem was to stop on calcar.The surgeon quickly used the marking pen to trace around the marked side of the prosthesis and inserted stem to the approximate position.Head retrialed and rom performed.The definitive head implanted and the wound washed and closed in layers.No impact to the patient was reported.
Additional Manufacturer Narrative
It was reported that during a total hip replacement, the surgeon noticed there wasn't any laser etching on the lateral side of the stem.The surgeon could not visualize where the stem was to stop on calcar.The surgeon quickly used the marking pen to trace around the marked side of the prosthesis and inserted stem to the approximate position.The associated cpcs collarless polished cemented high offset stem, used in treatment, was not returned for evaluation.Therefore the product analysis could not be performed.The review of manufacturing records was conducted and it 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 with the same batch number.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 or adverse event could not be corroborated.Possible causes could include but not limited to marking faded or marking illegible.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 the device or additional information be received, the complaint will be reopened.

• Brand Name: CPCS COCR PRIM HO 12/14 SZ 4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9194867
• Report Number: 1020279-2019-03662
• Device Sequence Number: 1879146
• Product Code: JDI
• UDI-Device Identifier: 03596010462176
• UDI-Public: 03596010462176
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K823727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/27/2025
• Device Model Number: 71312374
• Device Catalogue Number: 71312374
• Device Lot Number: 15GM17244
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 03/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1