MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP XLPE INSERT 53/28 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCMNTED

Model Number	75018958
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a hip revision surgery was performed due to infection.Liner and head exchanged.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.The clinical/medical team concluded, as this complaint is being handled through smith nephew's legal team, any responses to these queries are not immediately available to the members of smith nephew's complaint/regulatory team and are not expected to be available for several months.This is due to the delivery timeframe of patient medical information and device return being in the control of the patient's legal team, rather than smith nephew.The smith nephew's legal team has confirmed that once any additional relevant complaint information is received, (i.E.Reason for complaint, part/lot numbers, patient medical records, surgical reports, device availability, and dates of implantation/revision) it will be provided to the complaint/regulatory team, at which point the complaint/clinical medical task will be reopened for investigation.Therefore, a clinical assessment cannot be performed 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.Factors and/or potential causes that could contribute to the reported event have been identified in the risk management file.Product was sterilized according to sterilization release documentation from quality control.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: POLARCUP XLPE INSERT 53/28 NON-CEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCMNTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau
• MDR Report Key: 9474056
• Report Number: 9613369-2019-00104
• Device Sequence Number: 14115606
• Product Code: LPH
• UDI-Device Identifier: 07611996111484
• UDI-Public: 07611996111484
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2020

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 Expiration Date: 06/04/2026
• Device Model Number: 75018958
• Device Catalogue Number: 75018958
• Device Lot Number: B1912171
• Initial Date Received by Manufacturer: 11/24/2019
• Supplement Date Received by Manufacturer: 11/24/2019
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 01/20/2020
• 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: Required Intervention
• Patient Age: 71 YR