MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS STANDARD STEM 2 NON-CEMENTED; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER,

Catalog Number 75002696

Device Problem Failure to Align (2522)

Patient Problem Inadequate Osseointegration (2646)

Event Date 03/22/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case (b)(4).

Event Description

It was reported that, after a right tha had been performed on (b)(6) 2007 with bicon-plus, the patient presented a loosening of the bicon-plus titanium shell 3-49 non-cem and a sl-plus standard stem 2 non-cemented malalignment.This event was addressed via revision surgery on (b)(6) 2011 to explant the all devices.Patient's current status is unknown.This information was provided by the (b)(6), following a review of the data conducted in september 2021.

Manufacturer Narrative

H3, h6: a total of 84 revision surgeries involving bicon-plus devices was reported by the uk national joint registry.140 complaints were opened accordingly.A review of the device history record (dhr), of the complaint history (chr), of the instruction for use (ifu), of the risk management file (rmr) and of past escalation (per) was performed.No relevant supporting clinical information was provided.Based on insufficient information, 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.Based on the chr and dhr evaluation performed there is no indication that any failure to meet specification contributed to the reported events.The reported failure modes are outlined in the device instruction for use lit no 12.23 03/21.The occurrence and severity of the reported issues are in line with the risk plans.The root cause of the reported events was attributed to known inherent risks of the devices.No corrective actions have been initiated.

• Brand Name: SL-PLUS STANDARD STEM 2 NON-CEMENTED
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER,
• 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: 14140433
• MDR Text Key: 289488906
• Report Number: 9613369-2022-00215
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07611996000429
• UDI-Public: 7611996000429
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K143096
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/03/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 75002696
• Device Lot Number: F0603059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 04/19/2022
• Supplement Dates Manufacturer Received: 05/13/2022
• Supplement Dates FDA Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female