MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP XLPE INSERT 43/22 NON-CEM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number	75018942
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint reference: case-(b)(4).
Event or Problem Description
It was reported that the patient dislocated.And a closed reduction was performed and failed.Revision surgery was performed and implants of the same size were implanted.No patient information is available.
Additional Manufacturer Narrative
Results of investigation: it was reported that the patient dislocated the hip.A closed reduction was performed and failed.Therefore, a revision surgery had to be conducted.The device (75018942/ polarcup xlpe insert 43/22 non-cem) intended for use in treatment was not returned for investigation nor was a batch number communicated.An appropriate investigation could therefore not be conducted and the reported failure mode could not independently be confirmed.A review of the complaint history revealed five complaints reported for a similar issue.However, it cannot be determined if the additional complaints are related to the one in scope due to missing information.The ifu (lit.No.12.23 ed 05/16) lists dislocation as a known possible side effect resulting from a hip arthroplasty.A review of the risk management documentation verifies the failure mode and severity of the reported issue.Based on the limited information provided, a thorough medical assessment could not be performed.Complaint reference: (b)(4).

• Brand Name: POLARCUP XLPE INSERT 43/22 NON-CEM
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11069735
• Report Number: 9613369-2020-00273
• Device Sequence Number: 3310708
• Product Code: KWY
• UDI-Device Identifier: 07611996111323
• UDI-Public: 07611996111323
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 01/15/2021

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: 75018942
• Device Catalogue Number: 75018942
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/28/2020
• Supplement Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 01/15/2021
• 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