MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM STD TI/HA 2 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number	75100465
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number : case-(b)(4).
Event or Problem Description
It was reported that a revision surgery was performed due to an infection.Elevated temperature and crp noted.All implants removed and cement spacer implanted.The surgeon does not attribute blame to prosthesis.
Additional Manufacturer Narrative
H3, h6: it was reported that a revision surgery was performed due to an infection.Elevated temperature and crp noted.All implants removed and cement spacer implanted.The device, used in treatment, was not returned for evaluation, therefore further analysis was not possible.However, based on the communicated information, the product history could be reviewed.The production documentation as well as the sterilization certificate were reviewed, there were no deviations found.There were no further complaints reported for the batch in scope.The failure mode and the severity are covered through the corresponding risk management files.The ifu lit.No.12.23, ed.05/16 lists infection as a possible side effect.As no medical information was provided, an thorough assessment could not be conducted.Based on the information, the reported failure mode cannot independently be confirmed.The root cause stays undetermined after investigation, and is attributed to a known inherent risk.To date, further actions are not deemed necessary.Should additional information become available, this complaint will be reassessed.Smith and nephew will monitor this device for further similar issues.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, based on information provided, the first stage of a 2-stage revision with cement spacer was implanted.It was communicated that the requested medical documentation was not available; however, the surgeon reportedly did not attribute blame to the prosthesis.Reportedly the infection was the root cause of the revision; however, the source of the infection remains unknown.The patient impact beyond the reported infection and subsequent 1st-stage revision could not be determined.No further medical assessment could be rendered at this time.A review of the complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.A review of the sterilization records revealed the batch was sterilized within normal parameters.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to contamination, patient reaction, and post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: POLARSTEM STEM STD TI/HA 2 NON-CEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11712917
• Report Number: 9613369-2021-00166
• Device Sequence Number: 17250168
• Product Code: LZO
• UDI-Device Identifier: 07611996118568
• UDI-Public: 07611996118568
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K130728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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,Followup
• Report Date (Section B): 08/18/2021

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 Expiration Date: 03/24/2025
• Device Model Number: 75100465
• Device Catalogue Number: 75100465
• Device Lot Number: B1805548
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 05/14/2021; 08/16/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 05/14/2021; 08/18/2021
• 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: Required Intervention
• Patient Age: 68 YR