MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM LATERAL 3 CEMENTED; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED

Catalog Number	75002122
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, after a 2nd stage revision on (b)(6) 2020 due to a left thr infection, patient had another infection in the same hip therefore had a first stage revision left thr on (b)(6) 2021.It was indicated by a diseases specialist a revision surgery to remove all prosthesis as the organism causing the infection is susceptible to antibiotic that the patient is allergic.All prosthesis were removed.Patient outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Investigation results: it was reported that, after a 2nd stage revision on (b)(6) 2020 due to a left total hip replacement infection, patient had another infection in the same hip therefore had a first stage revision left total hip replacement on 15/01/2021.It was indicated by a diseases specialist, a revision surgery to remove all prosthesis as the organism causing the infection is susceptible to antibiotic that the patient is allergic to.All prosthesis were removed.Patient outcome is unknown.In this report the impact of the explanted polarstem standard ti/ha stem size 3 will be analyzed.The device, which intent use is in treatment, was not returned for investigation.The production records and sterilization certificate was analyzed.No deviations can be found which could explain the occurred infection.For the specific batch number no other complaint can be found.In our current instruction for use for hip implants 12.23 ed.05/16 infection is a mentioned possible risk factor for a total hip replacement.Our product specific risk file shows that the risk of an infection for this product is low.Per complaint details, a left tha revision surgery was performed approximately 1 month post second-stage revision to explant all prosthetic components due to development of another infection ¿as the organism causing infection is susceptible to antibiotic that patient has allergy to¿.Per correspondence, no consent was granted for the requested medical documentation.It was further communicated that an antibiotic spacer was used and the explants were sent for pathology testing and are not available at this time.Reportedly, an unspecified infection (possibly recurrent) was the root cause of the event; however, the source of the infection could not be concluded based on the limited information provided.No further medical assessment could be rendered at this time.Should clinically relevant documentation become available the medical investigation task may be re-evaluated.S+n will monitor this device for similar issues.

• Brand Name: POLARSTEM STEM LATERAL 3 CEMENTED
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11284790
• Report Number: 9613369-2021-00064
• Device Sequence Number: 4371942
• Product Code: LZO
• UDI-Device Identifier: 07611996096804
• UDI-Public: 07611996096804
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K130728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2021

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: 11/28/2025
• Device Catalogue Number: 75002122
• Device Lot Number: C1821527
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71344247/TITANIUMMODULARHEADSLV12/14TPR+0/19JT2835; 71344247/TITANIUMMODULARHEADSLV12/14TPR+0/19JT2835
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR