MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM COLLAR LAT. TI/HA 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Model Number 75018412

Device Problems Failure to Osseointegrate (1863); Loss of Osseointegration (2408)

Patient Problems Pain (1994); Inadequate Osseointegration (2646)

Event Date 05/24/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a hip replacement on (b)(6) 2021, the patient experienced thigh pain after being run over by a dog.The patient underwent revision surgery on (b)(6), 2022 due to aseptic loosening where the polarstem collar lat and the ti/ha 1was removed.The patient had previously had a femoral shaft fracture and the sclerotic bone inside the intramedullary canal is believed to be the reason the stem did not integrate properly.The current status of the patient is unknown.

Manufacturer Narrative

H3, h6: it was reported that, after a hip replacement on (b)(6) 2021, the patient experienced thigh pain after being run over by a dog.The patient underwent revision surgery on may 24, 2022 due to aseptic loosening where the polarstem collar lat and the ti/ha 1 and oxinium fem hd 12/14 32mm +4 were removed.The patient had previously had a femoral shaft fracture and the sclerotic bone inside the intramedullary canal is believed to be the reason the stem did not integrate properly.The current status of the patient is unknown.The complaint device polarstem collar lat.Ti/ha 1, used in treatment, was not returned for investigation hence the product evaluation could not be performed.A review of the batch record revealed no deviations from the standard manufacturing process.A review of the complaint history revealed no additional complaint for the batch in question.A review of the risk management documentation verifies the failure mode and severity of the reported issue.Review of past corrective actions was performed.No further escalation is required.The ifu (lit.No.12.23, ed.03/21) stated inadequate osseointegration among possible side effects resulting from hip arthroplasty.The medical investigation was performed.Based on the information provided, the patient being knocked over by the dog and the sclerotic bone inside of the intramedullary canal are the likely contributing factors to the reported aseptic loosening that led to the early revision.The patient impact beyond the revision cannot be determined.However, it was reported that the patient has recovered well from the surgery.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.Based on the performed investigations, the reported failure mode could not be confirmed independently since the complaint device was not available for investigation.A relationship between the reported event and the device cannot be confirmed.The reported device met manufacturing specifications upon release for distribution.No probable cause can be determined.This version of the device will be monitored for similar issues.This investigation is considered closed.Should the complaint device become available, the complaint will be reassessed.

• Brand Name: POLARSTEM COLLAR LAT. TI/HA 1
• 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: 14654992
• MDR Text Key: 293729034
• Report Number: 9613369-2022-00277
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 07611996103496
• UDI-Public: 07611996103496
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K143739
• 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: 07/27/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 75018412
• Device Catalogue Number: 75018412
• Device Lot Number: B2011101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 06/10/2022
• Supplement Dates Manufacturer Received: 07/22/2022
• Supplement Dates FDA Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2020
• 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: 71331954/R3 3 HOLE HA CTD ACET SHELL 54MM; 71339554/R3 0 DEGREE XLPE LNR 32MM X 54MM; OXINIUM FEM HD 12/14 32MM +4, LOT#:21AM08792; R3 0 DEGREE XLPE LNR 32MM X 54MM, LOT#:21FM14304; R3 3 HOLE HA CTD ACET SHELL 54MM, LOT#:20KM12403A
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male