MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN. POLARSTEM CEMENTED; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Catalog Number UNKNOWN

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

Patient Problem Unspecified Infection (1930)

Event Date 07/24/2018

Event Type  Injury  

Event Description

It was reported that, on literature review "ten-year follow-up of a cemented tapered stem", two (2) patients initially underwent thr primary implantation of a cemented polarstem and one of the following smith and nephew acetabular cup combinations: ep-fit cup, cemented polyethylene mueller cup or cementless anti-luxation mueller cup.After this procedure, these patients required the revision of all the hip prosthesis components due to an unspecified postoperative infection at sixteen (16) and seventeen (17) months after implantation, respectively.The outcome of both patients is not known.No further information is available.

Manufacturer Narrative

Internal complaint reference: (b)(4).Klasan, a., sen, a., dworschak, p., el-zayat, b.F., ruchholtz, s., schuettler, k.F.,.& heyse, t.J.(2018).Ten-year follow-up of a cemented tapered stem.Archives of orthopaedic and trauma surgery, 138(9), 1317-1322.Doi: https://doi.Org/10.1007/s00402-018-3002-1.

Manufacturer Narrative

The study of a.Klasan a.Et.Al.[1] reports "ten-year follow-up of a cemented tapered stem.It was reported that two (2) patients initially underwent thr primary implantation of a cemented polarstem and one of the following smith and nephew acetabular cup combinations: ep-fit cup, cemented polyethylene mueller cup or cementless anti-luxation mueller cup.After this procedure, these patients required the revision of all the hip prosthesis components due to an unspecified postoperative infection at sixteen (16) and seventeen (17) months after implantation, respectively.The outcome of both patients is not known.No further information is available.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 images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.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] klasan, a., sen, a., dworschak, p.Et al.Ten-year follow-up of a cemented tapered stem.Arch orthop trauma surg 138, 1317¿1322 (2018).Https://doi.Org/10.1007/s00402-018-3002-1.

• Brand Name: UNKN. POLARSTEM CEMENTED
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau TN CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau TN CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14718951
• MDR Text Key: 294928311
• Report Number: 9613369-2022-00304
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• 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: 07/19/2022
• 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
• Patient Outcome(s): Hospitalization; Other