MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HEAD 32 + 8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71303208
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during surgery, while opening the packaging of the femoral head, it got stuck to the piece itself.It was not possible to eliminate the entire plastic package attached to the product and procedure was concluded with a back-up device from smith and nephew and with a delay greater than 30 minutes.
Additional Manufacturer Narrative
H3, h6: the associated device packaging, used in treatment, was returned and evaluated.A visual inspection of the returned device packaging could not confirm the stated failure mode.Only the opened inner sterile tray and a chart-stick ware returned for evaluation.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.The probable cause for this event is likely inadequate packaging material.This failure mode has been previously identified.Since the manufacturing of the complaint device, a design change was implemented to eliminate/reduce the occurrence of this failure.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: COCR 12/14 FEM HEAD 32 + 8
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11010836
• Report Number: 1020279-2020-07443
• Device Sequence Number: 3594208
• Product Code: LPH
• UDI-Device Identifier: 03596010194206
• UDI-Public: 03596010194206
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K963509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2021

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: 11/19/2025
• Device Model Number: 71303208
• Device Catalogue Number: 71303208
• Device Lot Number: 15LT61780
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/26/2020
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1