MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP SHELL 45 CEMENTED; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	75017195
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/13/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was required due to a tumor ingress.
Additional Manufacturer Narrative
It was reported that a hip revision was required secondary to a ¿tumor ingress¿.The complained devices have not been returned for investigation.The devices could therefore not be evaluated and the stated failure mode not independently be confirmed.No medical documents were received for investigation.Without supporting clinical/medical documents a thorough investigation could not be performed.A review of the batch record revealed no deviations from the standard manufacturing process that could have contributed to the reported failure mode.A review of the complaint history revealed no other complaints for the batches in scope.Based on available information, there is no indication that the devices did not meet specification at the time of manufacturing.However, the root cause cannot clearly be identified and stays undetermined.The need for corrective action is not indicated.Nevertheless smith and nephew will continue to monitor the devices for similar issues.It was communicated that the customer does not want follow up questions and no more information will become available.This complaint is therefore considered closed.

• Brand Name: POLARCUP SHELL 45 CEMENTED
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; baar 06340 ; SZ 06340
• MDR Report Key: 8946028
• Report Number: 9613369-2019-00062
• Device Sequence Number: 11479066
• Product Code: LPH
• UDI-Device Identifier: 07611996096187
• UDI-Public: 07611996096187
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K070278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2019

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 Expiration Date: 07/19/2020
• Device Catalogue Number: 75017195
• Device Lot Number: A1303343
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 09/24/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 73 YR