MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKNOWN POLARCUP; ACETABULAR SHELL

Catalog Number	UNKNOWN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Literature case "dual-mobility cups in revision acetabular reconstructions: short-term outcomes in high-risk patients for instability".Author: goksel dikmen et al., the purpose of this study was to evaluate the performance of dual-mobility (dm) cup systems for revision total hip arthroplasty (rtha) in patients who had high risk for instability.30 patients underwent 34 hips rtha with dm cups.It was documented on the paper that 2 patients underwent re-revisions due to aseptic loosening.The reason of aseptic loosening was the migration of the cemented acetabular cups from the acetabulum in patients with severe hip abductor insufficiency.
Additional Manufacturer Narrative
Results of investigation: the study of goksel dikmen et.Al.[1] reports surgeries on 32 hips.A polarcup dual mobility system, used in treatment, was implanted.It is reported, that in two cases the patient suffered from a migration of the polarcup shell.The part and the batch number of this device are not known.Therefore, the batch record review and a complaint history review could not be performed.The reported failure mode might occur in some cases, which is stated as a side effect in the ifu lit.No.12.23 ed.05/16.The severity and the failure mode are covered through our risk management.As no device was received for investigation, a visual inspection could not be performed.No patient information nor any other medication documentation was provided, therefore, a thorough medical investigation could not be performed.Based on our investigations the failure mode cannot be confirmed and the root cause of the problem stays undetermined due to insufficient information.To date, no further actions will be taken.Smith and nephew will monitor the devices for further similar issues.

• Brand Name: UNKNOWN POLARCUP
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau ; SZ
• MDR Report Key: 10077642
• Report Number: 9613369-2020-00090
• Device Sequence Number: 3044882
• Product Code: JDI
• UDI-Device Identifier: 07611996118971
• UDI-Public: 7611996118971
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2020

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2020
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 08/07/2020
• 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: Hospitalization; Required Intervention