MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS INTEGR MIA STEM WITH TI/HA 5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	75000178
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924)
Date of Event	03/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a hemiarthroplasty had been performed on (b)(6) 2024, the patient fell and broke a bone.The surgeon did not think products failed, as the bone fracture was caused by the patient¿s fall.This adverse event was addressed by performing a revision surgery on (b)(6) 2024, in which all products were exchanged to competitor products.Patient's current health status is unknown.
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Additional Manufacturer Narrative
H3, h6: it was reported that after a hemiarthroplasty had been performed, the patient fell and broke a bone.The surgeon did not think products failed, as the bone fracture was caused by the patient¿s fall.This adverse event was addressed by performing a revision surgery, in which all products were exchanged to competitor products.Patient's current health status is unknown.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¿ resulting from a hip arthroplasty.As of the date of this medical investigation, the requested clinical documentation has not been provided.Therefore, the clinical root cause for the reported event could not be confirmed however, it was noted that ¿surgeon did not think products failed¿ and that the bone fracture was caused by the patient¿s fall.The patient impact was determined to be the reported broken bone and revision surgery.There is no evidence that the reported devices failed to meet manufacturing specifications upon release for distribution.The root cause of the event can be attributed to the adverse event caused partially by the user of the device.As reported, the patient fall cannot be discarded as a significant contributing factor, leading to a bone fracture.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 WITH TI/HA 5
• 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: 19177003
• Report Number: 9613369-2024-00048
• Device Sequence Number: 6341780
• Product Code: LZO
• UDI-Device Identifier: 07611996092806
• UDI-Public: 07611996092806
• 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: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2024

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: 75000178
• Device Lot Number: D2307164
• 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: 03/29/2024
• Supplement Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown