MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN. POLARSTEM (UNKN. TYPE); PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number UNKNOWN

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

Patient Problem Insufficient Information (4580)

Event Date 11/24/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that on literature review ""early benchmarking total hip arthroplasty implants using data from the michigan arthroplasty registry collaborative quality initiative (marcqi)"", an unknown number of patients had an unknown event after an initial tha due to osteoarthritis using a synergy / r3 combination.The events were treated via revision surgery.Patients outcome if known.No further information is available.

Event Description

It was reported that on literature review ""early benchmarking total hip arthroplasty implants using data from the michigan arthroplasty registry collaborative quality initiative (marcqi)"", an unknown number of patients had an unkown event after an initial tha due to osteoartrtitis using a synergy / r3 combination.The events were treated via revision surgery.Patients outcome if known.No further information is available.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).Chubb, h.A., cornish, e.R., hallstrom, b.R., & hughes, r.E.(2021).Early benchmarking total hip arthroplasty implants using data from the michigan arthroplasty registry collaborative quality initiative (marcqi).Orthopedic research and reviews, 13, 215.

Manufacturer Narrative

H3, h6: the study of heather a chubb et.Al.[1] reports "early benchmarking total hip arthroplasty implants using data from the michigan arthroplasty registry collaborative quality initiative (marcqi)".It was reported that an unknown number of patients had an unkown event after an initial tha due to osteoartrtitis using a polarstem / r3 combination.The events were treated via revision surgery.Patients outcome if known.As this is a literature complaint, the devices used in treatment, were not returned for investigation.The part and the batch number are not known.Therefore, it is not possible to investigate whether the reported device met manufacturing specification upon release for distribution.As no device was received for investigation, a visual inspection could not be performed.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 & 07/10) lists several possible adverse effects resulting from a hip arthroplasty.A medical investigation was conducted.The literature article was reviewed.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.Based on the conducted investigation the failure mode and the relationship between the device and the reported event cannot be confirmed.Due to insufficient information it is not possible to speculate about factors which could have contributed to the reported event.No probable cause can be determined.To date, no further actions will be taken.Should additional information become available, this complaint will be reassessed.Smith and nephew will monitor the devices for further similar issues.Chubb ha, cornish er, hallstrom br, hughes re.Early benchmarking total hip arthroplasty implants using data from the michigan arthroplasty registry collaborative quality initiative (marcqi).Orthop res rev.2021 nov 24;13:215-228.Doi: 10.2147/orr.S325042.Pmid: 34853539; pmcid: pmc8627892.Internal complaint reference: (b)(4).

• Brand Name: UNKN. POLARSTEM (UNKN. TYPE)
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• 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: 13831708
• MDR Text Key: 287912405
• Report Number: 9613369-2022-00054
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Other