MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM LAT.TI/HA 3 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Model Number	75100476
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	11/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that primary hip arthroplasty was performed in (b)(6) 2020.Hip revision had to be performed due to a proximal femoral fracture which likely occurred at time of primary surgery as per surgeon.The dr.Opened previous incision via a direct anterior approach.Dislocated hip.Primary stem and head removed with punch.Dr then prepared the femur as per a standard surgical technique.Size 2 lateral polar uncemented stem inserted.Size 36 -4 oxinium head also inserted.Intra-operative x-ray attended.
Additional Manufacturer Narrative
Investigation results: this complaint from australia reports a revision surgery the day after implantation secondary to a proximal femoral fracture.A polarstem lateral ti / ha stem size 3 was initially implanted, which intent use is in treatment.To date no adequate materials like the product itself or clinical / medical documents were provided to fully evaluate this complaint.The batch number was transmitted incorrectly, which is why a batch record review and a batch related complaint review could not be performed.For the specific article there is no other complaint which reported a periprosthetic fracture.The risk of a bone fracture is mentioned in our current risk management file and it is rated low.In our current instruction for use for hip implants on (b)(6) ed.On (b)(6) bone fracture is mentioned and a known possible side effect of a total hip replacement.At that time the root cause can not be determined.Should additional information will be available the case will be re-assessed.

• Brand Name: POLARSTEM STEM LAT.TI/HA 3 NON-CEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11058847
• Report Number: 9613369-2020-00266
• Device Sequence Number: 11437936
• Product Code: LWJ
• UDI-Device Identifier: 07611996118674
• UDI-Public: 07611996118674
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K130728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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 Model Number: 75100476
• Device Catalogue Number: 75100476
• Device Lot Number: B2027-07-20
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 02/24/2021
• 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: Hospitalization; Required Intervention