MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS INTEGR MIA STEM LAT. W. TI/HA 4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 75000189

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Bone Fracture(s) (1870); Arthralgia (2355); Inadequate Osseointegration (2646)

Event Date 07/19/2023

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that, after a tha surgery was performed on (b)(6) 2023, the patient experienced to pain, bone fracture and loosening of the stem.This adverse event was treated by a revision surgery on (b)(6) 2023, in which a sl-plus integr mia stem lat.W.Ti/ha 4 was exchanged to a competitor stem (versys crc).Patient's current health status is unknown.

Manufacturer Narrative

H3, h6: it was reported that, after a total hip arthroplasty surgery was performed on (b)(6) 2023, the patient experienced to pain, bone fracture and loosening of the stem.This adverse event was treated by a revision surgery on (b)(6) 2023, in which a sl-plus integr mia stem lat.W.Ti/ha 4 was exchanged to a competitor stem (versys crc), a oxinium fem hd 12/14 32mm +0 head and was exchanged to an s+n unknown head while the r3 xlpe liner, and the r3 cup were exchanged.The device intended for use in treatment was not returned for investigation.A product evaluation was not possible.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.The complaint history review for the complaint device revealed no additional complaints for the affected batch nor additional complaints for the same product number over the past 12 months with similar failure mode.There are no capa, pra/hhe, field actions related to the reported issue.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.The instructions for use (lit.No.12.23, ed.03/21) states "hip fracture" as a ¿potential adverse device effect¿, and "loosening of implant not related to bone-ingrowth" as a "potential medical device problem" in combination with the implantation of a hip prosthesis.No clinically sufficient data was provided to perform a medical investigation.The performed investigation does not lead to an accurately determined cause.There is no evidence that the reported devices failed to meet manufacturing specifications upon release for distribution.Due to insufficient information, it is not possible to indicate factors which could have contributed to the reported event.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.

• Brand Name: SL-PLUS INTEGR MIA STEM LAT. W. TI/HA 4
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-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: 17538080
• MDR Text Key: 321049652
• Report Number: 9613369-2023-00177
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07611996092912
• UDI-Public: 07611996092912
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122296
• 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
• Report Date: 09/05/2023

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: 75000189
• Device Lot Number: D2221589
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2023
• Initial Date FDA Received: 08/13/2023
• Supplement Dates Manufacturer Received: 09/04/2023
• Supplement Dates FDA Received: 09/05/2023
• Date Device Manufactured: 10/06/2022
• 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
• Treatment: OXINIUM FEM HD 12/14 32MM +0; R3 0 DEG XLPE ACET LNR 32MM X 48MM; R3 3 HOLE ACET SHELL MM48
• Patient Outcome(s): Required Intervention
• Patient Sex: Female