MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN. SL-PLUS MIA STEM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number UNKN1102903

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Hip Fracture (2349)

Event Date 10/19/2022

Event Type  Injury  

Manufacturer Narrative

Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.Case (b)(4).

Event Description

It was reported that, after a thr had been performed on (b)(6) 2016, the patient sustained a periprosthetic fracture around the femoral stem prosthesis and pain.A revision surgery was conducted on (b)(6) 2022 to treat this adverse event.During this procedure, a femoral stem from the sl-plus mia family was explanted and replaced with a competitors device.The initially implanted reflection acetabular cup and liner were retained within the patient's acetabulum.No further information is available.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: it was reported that, after a total hip replacement had been performed on 01-sep-2016, the patient sustained a periprosthetic fracture around the femoral stem prosthesis and pain.A revision surgery was conducted on 19-oct-2022 to treat this adverse event.During this procedure, a femoral stem from the sl-plus mia family was explanted and replaced with a competitors device.The initially implanted reflection acetabular cup and liner were retained within the patient's acetabulum.The device intended for use in treatment was not returned for investigation.A product evaluation was not possible.So, the mentioned failure mode cannot be confirmed.No batch number was communicated so the document history review was not possible.Due to insufficient information it is not possible to perform a review of past corrective actions.As the batch number and product number are unknown, it is not possible to perform a complaint history review.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.A review of the device labeling revealed that the instructions for use (lit.No.12.23, ed.03/21) states states "fracture" and "pain" as ¿potential adverse device effects¿ in combination with the implantation of a hip prosthesis.No clinically sufficient data was provided to perform a medical investigation.Based on the information provided to the complaint, it is not possible to confirm the reported failure mode.A relationship between the reported event and the device cannot be confirmed, the performed investigation do not lead to an accurately determined cause.Based on the available information it is not possible to investigate whether the reported device met manufacturing specifications upon release for distribution.Due to insufficient information, it is not possible to speculate about 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: UNKN. SL-PLUS MIA STEM
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• 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: 15790124
• MDR Text Key: 303576063
• Report Number: 9613369-2022-00593
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN1102903
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other