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

Catalog Number UNKN1100402

Device Problem Migration (4003)

Patient Problem Deformity/ Disfigurement (2360)

Event Date 01/01/1900

Event Type  Injury  

Manufacturer Narrative

Internal reference: (b)(4).

Event Description

It was reported that, according to data obtained from the endoprothesenregister - deutschland (eprd), a total of two thousand eight hundred fourteen (2814) patients underwent a thr procedure between (b)(6) 2013 and (b)(6) 2021 with a system that included a bicon-plus ti shell as the main acetabular component.From this cohort, three (3) patients underwent revision surgery on an unspecified date following a diagnosis of malposition/malalignment of the prosthesis.The identity of the devices explanted during these procedures and the prosthesis implanted in exchange remains unknown.Additional details regarding the clinical course of these patients are also unknown.The eprd provided this information as part of a cumulative statistical study regarding failure frequency.As such, there is no additional information available.

Manufacturer Narrative

H3, h6: according to data obtained from the endoprothesenregister - deutschland (eprd) [1], a total of two thousand eight hundred fourteen (2814) patients underwent a thr procedure between (b)(6) 2013 and (b)(6) 2021 with a system that included a bicon-plus ti shell as the main acetabular component.From this cohort, three (3) patients underwent revision surgery on an unspecified date following a diagnosis of malposition/malalignment of the prosthesis.The identity of the devices explanted during these procedures and the prosthesis implanted in exchange remains unknown.The complaint device, used in treatment, was not received for investigation and a visual inspection could not be performed.The exact part and batch number of the device is not known.Therefore, the batch record review could not be performed and it is not possible to investigate whether the reported devices met manufacturing specifications upon release for distribution.A complaint history review was performed.The occurrence of the reported failure mode is within its expected risk level as per risk management.Furthermore, the ifu indicates several possible adverse effects resulting from a hip arthroplasty.A review of the risk management documentation verifies the failure mode and severity of the reported issue.Due to insufficient information it is not possible to perform a review of past corrective actions.For the medical investigation, no relevant supporting clinical information could be provided.Therefore, a thorough clinical assessment cannot be performed at this time.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined.Should any additional clinical information be provided, this complaint will be re-evaluated.Based on the performed investigations, a relationship between the reported devices and the reported incidents cannot be excluded, but the root cause of the problem stays undetermined due to insufficient information.A relationship between the reported event and the device cannot be confirmed.Due to insufficient information it is not possible to speculate about factors which could have contributed to the reported event.To date, no further actions will be taken.Smith and nephew will monitor the devices for further similar issues.[1]: german arthroplasty registry (eprd).Smith & nephew bicon-plus ti shell.Germany.Internal complaint reference number: (b)(4).

• Brand Name: UNKN. BICON-PLUS SHELL
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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 ; 5123913905
• MDR Report Key: 15535442
• MDR Text Key: 301115432
• Report Number: 9613369-2022-00532
• Device Sequence Number: 1
• Product Code: JDI
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: UNKN1100402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2022
• 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: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention