MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN. POLARSTEM (UNKN. TYPE); PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number UNKNOWN

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

Patient Problem Hip Fracture (2349)

Event Date 01/01/2006

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Fiquet, a., & noyer, d.(2006).¿polarsystem¿ dual mobility hip prosthesis and ¿minimally invasive surgery¿(mis).Interactive surgery, 1(1), 51-55.Doi: 10.1007/s11610-006-0004-4.

Event Description

It was reported that, on literature review ""¿¿polarsystem¿¿ dual mobility hip prosthesis and ¿¿minimally invasive surgery¿¿ (mis)"", two (2) patients experienced an intraoperative merckel fissure during the implantation of a polarcup and a polarstem to treat either an osteoarthritis diagnosis or a neck fracture.These incidents were immediately treated by cerclage implantation without widening of the incision and with no consequence on operative outcomes.The outcome of the two (2) patients is unknown.No further information is available.

Manufacturer Narrative

Section h10: the study of a.Fiquet a.Et.Al.[1] reports ¿¿polarsystem¿¿ dual mobility hip prosthesis and ¿¿minimally invasive surgery¿¿ (mis)".It was reported that two (2) patients experienced an intraoperative merckel fissure during the implantation of a polarcup and a polarstem to treat either an osteoarthritis diagnosis or a neck fracture.These incidents were immediately treated by cerclage implantation without widening of the incision and with no consequence on operative outcomes.The outcome of the two (2) patients is unknown.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 complaint history review was performed.The occurrence of the reported failure mode is within its expected risk level as per risk management.Review of past corrective actions was performed.No further escalation is required.A review of the risk management documentation verifies the failure mode and severity of the reported issue.The instructions for use lists several possible adverse effects resulting from a hip arthroplasty.A medical investigation was conducted.The data presented in the aged article does not provide insight or relevance to current clinical outcomes for the product/device.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.Internal complaint reference number: (b)(4).[1] fiquet, a., noyer, d.¿polarsystem¿ dual mobility hip prosthesis and ¿minimally invasive surgery¿ (mis).Interact surg 1, 51¿55 (2006).Https://doi.Org/10.1007/s11610-006-0004-4 section h6 (impact code) was corrected.

• Brand Name: UNKN. POLARSTEM (UNKN. TYPE)
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR 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: 14706654
• MDR Text Key: 294910196
• Report Number: 9613369-2022-00291
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/05/2022

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 Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2022
• Initial Date FDA Received: 06/15/2022
• Supplement Dates Manufacturer Received: 07/18/2022
• Supplement Dates FDA Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: No
• 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: UNKN. POLARCUP SHELL (UNKN. TYPE)
• Patient Outcome(s): Other