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

Catalog Number	75000177
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	11/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint number: case-(b)(4).
Event or Problem Description
It was reported that, after a thr surgery performed on (b)(6) 2023, it was noticed that the patient had a bone fracture around the sl-plus mia ha stem.It is possible that the bone was already fractured during primary surgery.A revision surgery was performed due to pain and bone fracture on (b)(6) 2023.The stem and femoral head were exchanged to s+n back up device (slr-plus, oxinium head).Accord cable was also used.The cup and liner were remained.The patient current health status is unknown.Further information is unknown and unavailable.
Additional Manufacturer Narrative
H3, h6: it was reported that, after a total hip replacement surgery performed on (b)(6) 2023, it was noticed that the patient had a bone fracture around the sl-plus mia ha stem.It is possible that the bone was already fractured during primary surgery.A revision surgery was performed due to pain and bone fracture on (b)(6) 2023.The stem and femoral head were exchanged to s+n back up device (slr-plus, oxinium head).Accord cable was also used.The cup and liner were remained.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.A review of past corrective actions was performed.No further escalation is required.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¿ 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.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.E1 (name prefix/title).

• Brand Name: SL-PLUS INTEGR MIA STEM WITH TI/HA 4
• Common Device Name: 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: 18423038
• Report Number: 9613369-2023-00229
• Device Sequence Number: 12753790
• Product Code: LZO
• UDI-Device Identifier: 07611996092790
• UDI-Public: 07611996092790
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2024

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 Catalogue Number: 75000177
• Device Lot Number: D2305239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 12/31/2023
• Supplement Report FDA Received Date: 01/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71337648/R3 20 DEG XLPE ACET LNR 32MM X 48MM; 71338663/R3 MULTI HOLE ACETABULAR SHELL 48MM; 71343208/OXINIUM FEM HD 12/14 32MM +8
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female