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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Hip Fracture (2349)

Event Date 06/07/2022

Event Type  Injury  

Event 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.

Manufacturer Narrative

Internal complaint reference: case-2022-00108292-1.

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
• Type of Device: 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
• MDR Text Key: 294805643
• Report Number: 9613369-2022-00321
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 07611996118674
• UDI-Public: 07611996118674
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K130728
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 06/07/2022
• Initial Date FDA Received: 06/24/2022
• Supplement Dates Manufacturer Received: 08/03/2022
• Supplement Dates FDA Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OXINIUM FEM HD 12/14 36 MM +0, LOT#:21GM21330
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 75 YR