MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS STANDARD STEM 5 NON-CEMENTED; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER

Model Number	75002703
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/12/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a right tha had been performed on (b)(6) 2015, the patient suffered a peri-prosthetic fracture on the sl-plus standard stem 5 non-cemented.This event was addressed via revision surgery on (b)(6) 2015 to explant head and stem.Patient health status is not known.This information was provided by the national joint registry of the (b)(6), following a review of the data conducted in september 2021.Inspection of the data shows that the calculated ptir (revision rate per one hundred patient years of implantation) of bicon-plus is above the average 071 (0.57-0.88) for their group ptir¿s 0.38.Further information will not become available.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional 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 5 NON-CEMENTED
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/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: 14079754
• Report Number: 9613369-2022-00080
• Device Sequence Number: 2097059
• Product Code: KWY
• UDI-Device Identifier: 07611996078671
• UDI-Public: 07611996078671
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K072852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2018
• Device Model Number: 75002703
• Device Catalogue Number: 75002703
• Device Lot Number: F1127680
• 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: 03/22/2022
• Supplement Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 04/11/2022
• Supplement Report FDA Received Date: 06/03/2022
• Date Device Manufactured: 01/01/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 15 YR
• Patient Sex: Male
• Patient Weight: 60 KG