MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY HO POR PL HA SZ 8; PRSTHSS,HIP,SMICNSTRND,MTLPLYMR,CMNTD

Catalog Number	71357108
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/22/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed because the implant have subsided.
Additional Manufacturer Narrative
The associated complaint device was not returned.The medical/clinical team concluded, related to (b)(4).It was reported that a revision surgery was performed due to implant subsidence.However, per email notification the sales rep already answered that the devices will not return and no medical information is available.Without the explant or the requested clinical information, the root cause of the implant subsidence cannot be concluded.The future impact to the patient beyond the revision cannot be concluded.No further clinical/medical assessment is warranted at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: ANTHOLOGY HO POR PL HA SZ 8
• Common Device Name: PRSTHSS,HIP,SMICNSTRND,MTLPLYMR,CMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7283979
• Report Number: 1020279-2018-00216
• Device Sequence Number: 10793796
• Product Code: JDI
• UDI-Device Identifier: 03596010559630
• UDI-Public: 03596010559630
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K052792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2018

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: Physician
• Device Catalogue Number: 71357108
• Device Lot Number: 17EM22910
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/31/2018
• Supplement Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 04/11/2018
• 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