MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN. POLARCUP PLASTIC INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	75018955
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after primary thr, a revision surgery was performed due to a dislocation.The polarcup xlpe insert 47/28 non-cem was explanted.The outcome of the patient is unknown.
Additional Manufacturer Narrative
Investigation results: it was reported that, after primary thr, a revision surgery was performed due to a dislocation.A oxinium fem, redapt stem and a polarcup xlpe insert (75018955) were explanted.The device 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.Based on the limited information provided, a thorough medical assessment could not be performed.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, the root cause of the reported issue cannot be determined and the need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint is considered closed.This complaint will be reopened should additional information or the device be received.

• Brand Name: UNKN. POLARCUP PLASTIC INSERT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11305594
• Report Number: 9613369-2021-00067
• Device Sequence Number: 1219902
• Product Code: LPH
• UDI-Device Identifier: 07611996111453
• UDI-Public: 07611996111453
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2021

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: 75018955
• Device Catalogue Number: UNKN1102305
• Device Lot Number: B2007644
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 04/06/2021
• 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
• Patient Weight: 60