MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP SHELL TI-PLASMA/HA 55 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	75100442
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to the consequences of his right hip replacement, still exhibiting a jump phenomenon that almost permanently invalidates and hinders overall recovery.
Additional Manufacturer Narrative
This complaint reports a male patient with a ¿still exhibiting a jump phenomenon (snap) that almost permanently invalidates and hinders overall recovery.¿ it has also been reported that the patient complaint of pain after surgery.A polarcup shell and insert have been returned for investigation.A visual inspection confirmed that the devices were used in treatment.Visual inspection and an assessment of material characteristics of the polarcup shell and insert observed scratches and patterns on the articulating surface, indicating that foreign particles have been captured in between shell and insert.It cannot be ruled out that this might have contributed to the reported issue.The whitish residues on the outer sphere of the shell could not conclusively be identified.A review of the provided operative report did not reveal any information surrounding the reported ¿jump phenomenon¿, which resulted in the revision.Without additional supporting relevant medical records, a thorough clinical assessment could not be performed.A review of the batch record revealed no deviation from the standard manufacturing process that could have contributed to the reported issue.For both devices the cup and the insert, no complaints have been reported for a similar issue.A review of the device labeling revealed that the ifu (lit.No.12.23 ed 05/16) states "dislocation, subluxation, insufficient range of movement¿ as a known possible side effects in combination with the implantation of a hip prosthesis.The risk management documentation verifies the failure mode and severity of the reported issue.Based on the executed investigation steps and available information the root cause for the reported issue could not be determined conclusively and stays undetermined.The need for corrective action is not indicated.Smith + nephew will continue to monitor the devices for similar issues.The returned devices will be retained.

• Brand Name: POLARCUP SHELL TI-PLASMA/HA 55 NON-CEM
• 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: 9313356
• Report Number: 9613369-2019-00088
• Device Sequence Number: 2374414
• Product Code: LPH
• UDI-Device Identifier: 07611996118339
• UDI-Public: 07611996118339
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K122244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2020

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 Expiration Date: 11/19/2021
• Device Model Number: 75100442
• Device Catalogue Number: 75100442
• Device Lot Number: B1412206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 04/20/2020
• 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