MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RF FSO CER ACET COMP 56MM; PRSTHSS, HP, SMI-CNSTRIND, UNCMNTED, MTL/PLYMR,PROS

Model Number	71332056
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had a ho size 8 anthology stem put in with the old reflection ceramic system cup since 9 year ago.The patient had some pain over the last few months but then presented with acute pain.X-rays were taken and possibly bloods run and revision surgery was performed.The ceramic liner was broken and that was the reason for revision.When they opened up the liner was in 3-4 small pieces and the rest had disintegrated! there was a large amount of black fluid around all the prosthesis.
Additional Manufacturer Narrative
It was reported that patient had a revision surgery performed due to pain.During surgery, the ceramic liner was found broken.There was a large amount of black fluid around all the prosthesis.The affected complaint devices, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.However, pictures were provided and confirmed the stated failure.As device information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the devices failed to meet specifications.A relationship, if any, between the devices and the reported incident could not be corroborated.A clinical analysis noted that x-rays and photos of the explanted devices and fluid have been reviewed and confirmed the reported event.No additional medical documents were received for investigation.Therefore no further medical assessment can be performed at this time.Based on this investigation, the need for corrective action is not indicated.The revision occured approximately 9 years post implantation.Some potential causes of the reported event could include but are not limited to traumatic injury, joint tightness or patient conditions.Without the return of the actual products involved and no patient medical records available, our investigation of this report is inconclusive.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.

• Brand Name: RF FSO CER ACET COMP 56MM
• Common Device Name: PRSTHSS, HP, SMI-CNSTRIND, UNCMNTED, MTL/PLYMR,PROS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9855874
• Report Number: 1020279-2020-00931
• Device Sequence Number: 2533389
• Product Code: MBL
• UDI-Device Identifier: 00885556021316
• UDI-Public: 00885556021316
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2020

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: No Information
• Device Model Number: 71332056
• Device Catalogue Number: 71332056
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 11/02/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention