MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS INTEGR MIA STEM LAT. W. TI/HA 6; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Model Number	75000191
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Event or Problem Description
It was reported that, during the course of a hip hemi arthroplasty for hip fracture, a sl-plus integr mia stem lat.W.Ti/ha 6 was determined necessary to provide a stable hip construct.After the stem was inserted, it was determined that the implant was expired (expiration date 6/2021).The charge nurse was notified and a decision was made to continue with the procedure for the following reasons: a spare implant could not be delivered to the or in less than 1.5 hours, the charge nurse determined the risk of waiting was not acceptable.The use of a standard offset was deemed also not an option due to a less stable hip construct.A risk for a unstable repair was also deemed unacceptable.The procedure was completed with the same device without delays.The patient outcome is unknown.
Additional Manufacturer Narrative
H3, h6: it was reported that, during the course of a hip hemi arthroplasty for hip fracture, a sl-plus integr mia stem lat.W.Ti/ha 6 was determined necessary to provide a stable hip construct.After the stem was inserted, it was determined that the implant was expired (expiration date 6/2021).The charge nurse was notified and a decision was made to continue with the procedure for the following reasons: a spare implant could not be delivered to the or in less than 1.5 hours, the charge nurse determined the risk of waiting was not acceptable.The use of a standard offset was deemed also not an option due to a less stable hip construct.A risk for a unstable repair was also deemed unacceptable.The procedure was completed with the same device without delays.The device, used in treatment was not returned for investigation.The production documentation and the complaint history were reviewed.There are no indications that the part failed to match specification at the time of manufacturing.The risk is in line with the current risk management.According to ifu lit.No.12.23, ed.03/21 implants shall not be used if beyond expiration date, noted on the label: "the implants shall not be used in any surgical procedure after the expiration date printed on each device label.Careful planning is recommended to assure that all products provided for a surgery are within their expiration date.Implants, implant parts and instruments that can no longer be used may be returned to the manufacturer for proper disposal free of charge." review of past corrective actions was performed.No further escalation is required.Based on the available information a thorough investigation was not possible.The patient impact beyond what was reported cannot be assessed.The reviewed labels confirm the expiration date mentioned in the complaint description, therefore the relationship between the reported event and the device can be confirmed.The root cause of this issue is attributed to an user error, since devices beyond the expiration date shall not be used.To date, the need for further actions is not indicated.Smith and nephew is monitoring this device for further similar issues.Should additional information become available, this complaint will be reopened.

• Brand Name: SL-PLUS INTEGR MIA STEM LAT. W. TI/HA 6
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• 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: 13205749
• Report Number: 9613369-2022-00004
• Device Sequence Number: 4549796
• Product Code: LWJ
• UDI-Device Identifier: 07611996092936
• UDI-Public: 07611996092936
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K122296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/11/2021
• Device Model Number: 75000191
• Device Catalogue Number: 75000191
• Device Lot Number: A1407239
• 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: 12/24/2021
• Supplement Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 01/10/2022
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2014
• 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 Sex: Unknown