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

Catalog Number 75000189

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 03/28/2024

Event Type  Injury  

Event Description

It was reported that, after a thr surgery had been performed on (b)(6) 2024, it was found that the incorrect stem was implanted.The sl-plus integr mia stem with ti/ha 4 had been planned to be implanted, but a sl-plus integr mia stem lat.W.Ti/ha 4 was opened and implanted instead.There is no health harm to the patient at this time.

Manufacturer Narrative

Internal reference number: (b)(4).

Manufacturer Narrative

The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.Use error did not lead to a device-related death or serious injury.This event is not reportable pursuant to applicable regulations.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: SL-PLUS INTEGR MIA STEM LAT. W. TI/HA 4
• Type of Device: 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: 19177421
• MDR Text Key: 340999974
• Report Number: 9613369-2024-00047
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07611996092912
• UDI-Public: 07611996092912
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/13/2024

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: 75000189
• Device Lot Number: D2305522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/24/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other