MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HD 28 -3; PROSTHESIS, HIP,SMICONSTRAIND, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71302803
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/08/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the surgeon has removed the 28mm cobalt chrome head -3 and has noticed the item has excessive wear and is heavily oxidised.
Additional Manufacturer Narrative
The associated cobalt chrome femoral head and reflexion liner were returned and evaluated.A lab analysis performed on the received devices indicated that scratches were observed on the articular surface of the head as well as near the female taper.Discoloration due to absorption of biological fluid was observed on the backside of the liner.Scratches on the lateral surface as well as damage & discoloration to the antiversion lip are also noted.Sem images to the antiversion lip damage & discoloration lead to an additional energy dispersive x-ray analysis which showed high concentrations of carbon.Antiversion lip damage is likely due to stem neck impingement.Sem images of the scratches and damages to the femoral head lead to additional edx analysis which revealed titanium (ti) metal transfer on the articular surface of the femoral head, and iron (fe) on the rim damage, near the female taper.Our clinical evaluation noted that no clinical supporting documentation has been provided for inclusion in this investigation.Without the requested clinical information, a thorough clinical/medical investigation cannot be rendered.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.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.Should additional information be received, the complaint will be reopened.

• Brand Name: COCR 12/14 FEM HD 28 -3
• Common Device Name: PROSTHESIS, HIP,SMICONSTRAIND, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7533323
• Report Number: 1020279-2018-00990
• Device Sequence Number: 10821279
• Product Code: LPH
• UDI-Device Identifier: 03596010194121
• UDI-Public: 03596010194121
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K963509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2018

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 Expiration Date: 05/28/2016
• Device Catalogue Number: 71302803
• Device Lot Number: 06EM14122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 11/05/2018
• 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