MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR FEM HD GT 28OD +0; PROSTHESISHIPSEMI-CONSTRAINEDMETALPOLYMERPOROUSUNCEMENTED

Model Number	71302800
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, it was found an inconsistency on the labeling of the product.There was a marking of the outer packaging of the co-cr implant and a marking of the sterile packaging of not for use with co-cr parts.A replacement of smith and nephew was used.The patient was not injured, the operation ended well for him.
Additional Manufacturer Narrative
It was reported that during surgery, it was found an inconsistency on the labeling of the product.There was a marking of the outer packaging of the co-cr implant and a marking of the sterile packaging of ¿not for use with co-cr parts¿.The affected device, used in treatment, was not returned for evaluation.However, pictures were provided which confirmed the stated failure.Our investigation revealed that the employee inadvertantly sticked the red warning label to the related tray.A root cause for this failure is determined as a human error.Based on this investigation, the corrective action is indicated.A review of the manufacturing records for the listed batch 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.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.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.We consider this investigation closed.

• Brand Name: COCR FEM HD GT 28OD +0
• Common Device Name: PROSTHESISHIPSEMI-CONSTRAINEDMETALPOLYMERPOROUSUNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038246
• MDR Report Key: 9951749
• Report Number: 1020279-2020-01265
• Device Sequence Number: 3272597
• Product Code: LPH
• UDI-Device Identifier: 03596010194114
• UDI-Public: 03596010194114
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K963509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2023

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 Model Number: 71302800
• Device Catalogue Number: 71302800
• Device Lot Number: 19GT25134
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 03/26/2020
• Supplement Date Received by Manufacturer: 07/22/2020; 08/25/2023
• Initial Report FDA Received Date: 04/11/2020
• Supplement Report FDA Received Date: 07/30/2020; 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown