MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP XLPE INSERT 22/45; PROSTHSIS,HIP,SEMI-CONSTRAINED, METAL/POLYMR,POROUS UNCMNTED

Catalog Number	75018943
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to hip dislocation.
Additional Manufacturer Narrative
Results of investigation:the associated complaint devices were not returned.The clinical/medical team concluded, no clinical relevant documents were provided to conduct a thorough medical assessment.No medical assessment is warranted at this time.This complaint will be re-evaluated if more information becomes available.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.Credit cannot be issued for the devices.
Additional Manufacturer Narrative
The associated polarcup insert and oxinium femoral head were not returned for evaluation.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.The devices were manufactured in 2016.A review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.A clinical evaluation noted that no clinical relevant documents were provided to conduct a thorough medical assessment.Thus, no medical assessment is warranted at this time.Without the return of the actual product involved, our investigation of this report is inconclusive.There is no information that would suggest the implanted devices failed to meet specifications.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: POLARCUP XLPE INSERT 22/45
• Common Device Name: PROSTHSIS,HIP,SEMI-CONSTRAINED, METAL/POLYMR,POROUS UNCMNTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar, TN 06340 ; SZ 06340
• MDR Report Key: 7485182
• Report Number: 1020279-2018-00842
• Device Sequence Number: 1476552
• Product Code: LPH
• UDI-Device Identifier: 07611996111330
• UDI-Public: 07611996111330
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K110135
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/08/2019

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: 75018943
• Device Lot Number: B1710099
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/08/2018
• Supplement Date Received by Manufacturer: 04/08/2018; 04/08/2018
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 09/13/2018; 03/08/2019
• 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: Other; Required Intervention
• Patient Age: 81 YR