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

Catalog Number UNKNOWN

Device Problems Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Pain (1994); Insufficient Information (4580)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference (b)(4).Note- this patient is the same that underwent a sl-plus revision surgery conducted on (b)(6) 2023.This event was reported to fda under manufacturer report number 9613369-2024-00002 (internal complaint reference (b)(4)).

Event Description

It was reported that, after undergoing a right primary thr surgery on (b)(6) 1998, the patient experienced pain and was diagnosed with loosening of a bicon acetabular cup.Due to this complication, a revision surgery was carried out on (b)(6) 2019, in which the cup and femoral head components were exchanged for competitor devices.

Event Description

It was reported that the patient had a primary right tep on (b)(6) 1997 and after undergoing several right hip revision surgeries, on (b)(6) 1998 a bicon cup was implanted.The patient had other revision surgeries in (b)(6) 1998 and (b)(6) 2008, but no further information is available.However, in a revision surgery performed on (b)(6) 2019, it was reported that the patient had a competitor cup implanted.It is unknown when, where or why the bicon cup was explanted and no further information is available.

Manufacturer Narrative

Section h10: it was reported that the patient had a primary right total endoprosthesis on 1997 and after undergoing several right hip revision surgeries, on (b)(6) 1998 a bicon cup was implanted.The patient had other revision surgeries in 1998 and 2008, but no further information is available.However, in a revision surgery performed on 01-jul-2019, it was reported that the patient had a competitor cup implanted.It is unknown when, where or why the bicon cup was explanted and no further information is available.The device intended for use in treatment was not returned for investigation.A product evaluation was not possible.No batch number was communicated so the production history review was not possible.Due to insufficient information it is not possible to perform a review of past corrective actions.As the product number and batch number are unknown, it is not possible to perform a complaint history review- a review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.Insufficient information was made available to determine the revision of the instructions for use applicable to the device at the time of manufacturing.However, a review of the current revision was conducted and it revealed that the instructions for use (lit.No.12.23, ed.03/21) lists several ¿potential adverse device effect¿ from a hip arthroplasty.The bicon cup was implanted in 1998.Medical records for a 2008 revision were not provided.It was noted as a ¿changeover¿ however, the clinical indication and/or list of explanted implants were not provided.Therefore, it is unknown if the 52-gauge bicon cup remained in situ and was the explanted total endoprosthesis cup noted in the (b)(6) 2019 revision.It cannot be concluded there was a malperformance of the implant.The performed investigation does not lead to an accurately determined cause.Based on the available information it is not possible to investigate whether the reported device met manufacturing specifications upon release for distribution.There is no need for further actions because of the limited information provided.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.Internal complaint reference number: (b)(4).

Manufacturer Narrative

H11- corrected data.B5- describe event or problem.

Event Description

It was reported that the patient had a primary right tep on 1997 and after undergoing several right hip revision surgeries, on (b)(6)1998 a bicon cup was implanted.Twenty (20) years later, the patient was diagnosed with acetabular loosening of a bicon cup and experienced pain.Therefore, a revision surgery was carried out on (b)(6) 2019, during which the cup and femoral head components were exchanged for competitor devices.No further complications regarding this event were reported.

• Brand Name: UNKN. BICON-PLUS SHELL
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• 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: 18891185
• MDR Text Key: 337510605
• Report Number: 9613369-2024-00020
• Device Sequence Number: 1
• Product Code: MBL
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 04/10/2024
• 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: BIOLOX HEAD SIZE 28 LONG.; SL-PLUS STEM SIZE 0: PART = 75002718, LOT = 94.336.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female