MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN. POLARCUP SHELL CEMENTED; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number UNKNOWN

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 02/01/2022

Event Type  Injury  

Event Description

It was reported that on literature review "treatment of severe acetabular bone loss using a tantalum acetabular shell and a cemented monoblock dual mobility acetabular cup", one (1) patient underwent tha revision surgery of an unspecified prosthesis due to chronic pelvic discontinuity.During this procedure, a tantalum shell (zimmer) was fixed to the acetabulum with several screws and a dual mobility polarcup was trailed and cemented into the tantalum shell.After this procedure, the patient sustained a wound drainage eight (8) weeks after reconstruction concerning for deep infection and was taken to the operating room for irrigation and debridement with exchange of the modular components.Lifelong oral suppressive antibiotics were administered upon this intervention.The outcome of this patient is unknown.No further information is available.

Manufacturer Narrative

Internal complaint reference: (b)(4).Melnic, c.M., cohen-levy, w.B., lozano-calderon, s.A., & heng, m.(2022).Treatment of severe acetabular bone loss using a tantalum acetabular shell and a cemented monoblock dual mobility acetabular cup.Jaaos-journal of the american academy of orthopaedic surgeons, 30(3), e301-e306.Doi: 10.5435/jaaos-d-21-00433.

Manufacturer Narrative

H3, h6: the study of melnic cm et.Al.[1] reports "treatment of severe acetabular bone loss using a tantalum acetabular shell and a cemented monoblock dual mobility acetabular cup".It was reported that one (1) patient underwent tha revision surgery of an unspecified prosthesis due to chronic pelvic discontinuity.During this procedure, a tantalum shell (zimmer) was fixed to the acetabulum with several screws and a dual mobility polarcup was trailed and cemented into the tantalum shell.After this procedure, the patient sustained a wound drainage eight (8) weeks after reconstruction concerning for deep infection and was taken to the operating room for irrigation and debridement with exchange of the modular components.Lifelong oral suppressive antibiotics were administered upon this intervention.The outcome of this patient 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 ifu (lit.No.12.23 ed 03/21) lists several possible adverse effects resulting from a hip arthroplasty.A medical investigation was conducted.It should be noted the literature review notes mixed-manufacturer components.The ifu (lit.No.12.23 ed 03/21) warns, ¿implants and implant components of smith & nephew orthopaedics ag must not be combined with other manufacturer implants.¿ however, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.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.

• Brand Name: UNKN. POLARCUP SHELL CEMENTED
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS 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: 14789214
• MDR Text Key: 295055803
• Report Number: 9613369-2022-00316
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/29/2022

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2022
• Initial Date FDA Received: 06/23/2022
• Supplement Dates Manufacturer Received: 07/25/2022
• Supplement Dates FDA Received: 07/29/2022
• 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): Required Intervention