MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HD 32 + 4; PRSTHSSHIPSMI-CNSTRINDMTAL/PLYMRPROUSUNCMNTD

Model Number	71303204
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to pain and elevated metal ion levels.Supected trunionosis of a cocr femoral head on a titanium alloy uncemented polarstem.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device has signs of damage from implantation.The device was manufactured in 2017.The medical investigation concluded that a revision on a cocr femoral head secondary to ¿pain, elevated metal ions and suspected trunnionosis¿.No metal ion levels were provided for this investigation.No clinical/medical supporting documents were provided.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.The head was returned for evaluation; however, the inspection did not reveal any answers regarding the complaint.The impact to the patient beyond the revision surgery and the recovery cannot be concluded.The root cause of the pain, elevated metal ion levels and suspected trunnionosis cannot be concluded with the information provided.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.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Pain is a potential complication associated with any surgery.Some potential probable causes could include patient reaction or a post-operative healing issue.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.

• Brand Name: COCR 12/14 FEM HD 32 + 4
• Common Device Name: PRSTHSSHIPSMI-CNSTRINDMTAL/PLYMRPROUSUNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9558084
• Report Number: 1020279-2020-00150
• Device Sequence Number: 11348292
• Product Code: LPH
• UDI-Device Identifier: 03596010194190
• UDI-Public: 03596010194190
• Combination Product (Y/N): N
• PMA/510(K) Number: K963509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2020

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
• Operator of Device: Health Professional
• Device Model Number: 71303204
• Device Catalogue Number: 71303204
• Device Lot Number: 17FT88875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 03/19/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention