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 Codes	Bone Fracture(s) (1870); Hip Fracture (2349)
Date of Event	06/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a thr have been performed on (b)(6) 2022, when the patient was chopping wood, tripped and fell heavily on his operative side causing a peri-prosthetic fracture 5/52 post daa surgery.An revision surgery was performed on (b)(6) 2022 to treat the adverse event using orif, cabling with trochanteric plate/cables, redapt stem, ox head.This was a revision surgery, not attributed to prosthesis.Further patient information is unknown.
Additional Manufacturer Narrative
Internal complaint reference: case-2022-00108292-1.
Additional Manufacturer Narrative
H3, h6: it was reported that after a total hip replacement have been performed on (b)(6) 2022, when the patient was chopping wood, tripped and fell heavily on his operative side causing a peri-prosthetic fracture 5/52 post direct anterior approach surgery.A revision surgery was performed on (b)(6) 2022 to treat the adverse event using orif (open reduction and internal fixation), cabling with trochanteric plate/cables, redapt stem, oxinium head.The device, used in treatment, was not returned for investigation.A product evaluation could therefore not be performed.The performance of the device is within the risks that are anticipated in the risk management documentation of the product, both in occurrence and severity.A complaint history review was performed on the reported batch number.No additional complaints for the batch in scope were detected.Review of past corrective actions was performed and no further escalation is required.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode bone fracture.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.The peri-prosthetic fracture and subsequent revision were reported as related to the patient's fall and is not associated with a mal-performance of the implant.The patient impact beyond the revision and expected transient post-operational convalescence period cannot be determined.The reported failure mode bone fracture is stated as a potential adverse device effects in the hip instruction for use of smith and nephew (lit.No.12.23 ed.03/21).Based on the available information, the reported failure mode bone fracture cannot be confirmed.There is no confirmed relationship between the reported event and the device.Should more information become available, the investigation will be reopened.No further clinical assessment is warranted and no further actions are deemed necessary at the time.Smith+nephew will continue to monitor this device for similar issues.

• 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14807234
• Report Number: 9613369-2022-00321
• Device Sequence Number: 17354613
• 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
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2022

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: C2138556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2022
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OXINIUM FEM HD 12/14 36 MM +0, LOT#:21GM21330
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Unknown